TAPE MEASURE
FDA 510(k) clearance K790089 · decided 1979-03-06
Clearance details
- K-number
- K790089
- Device name
- TAPE MEASURE
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-17
- Decision date
- 1979-03-06
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- FTY
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Noxilizer Surgical Ruler (K160501) | Noxilizer, Inc. | 2016-05-26 |
| DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064) | S-E Sales & Distribution, Inc. | 1995-05-19 |
| OLYMPIC AUTO-LENGTH (K934930) | Olympic Medical Corp. | 1993-12-29 |
| OLYMPIC INFA-LENGTH (K932112) | Olympic Medical Corp. | 1993-07-22 |
| STRYKER PRESSURE MONITOR SYSTEM (K883485) | Stryker Corp. | 1988-09-13 |
| PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (K880441) | Plane Iii, Inc. | 1988-02-18 |
| TUMORIMETER (K874352) | Cancer Technologies, Inc. | 1987-11-23 |
| TEMPLATE (K873470) | Cox-Uphuff Intl. | 1987-09-08 |
| LN 100 BREAST MARKER (K872319) | Instrumentation Industries, Inc. | 1987-08-11 |
| KUNDIN WOUND GAUGE (K863409) | Jane I. Kundin | 1986-09-29 |
| PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (K862576) | Professional Services For Surgeons, Ltd. | 1986-07-15 |
| PS2 BRAND MAMMAPLASTY (K860912) | Professional Services For Surgeons, Ltd. | 1986-03-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |