LN 100 BREAST MARKER
FDA 510(k) clearance K872319 · decided 1987-08-11
Clearance details
- K-number
- K872319
- Device name
- LN 100 BREAST MARKER
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-17
- Decision date
- 1987-08-11
- Days to decision
- 55 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
- Bethel Park, PA, 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 |
| 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 |
| RULER (K854892) | Euro-Med Intl. | 1985-12-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE CHANGERS (P800068/S002) | Instrumentation Industries, Inc. | 1999-11-04 |
| ENDOTRACHEAL TUBE CHANGER (P800068/S001) | Instrumentation Industries, Inc. | 1999-07-23 |
| ENDOTRACHEAL TUBE CHANGER (P800068) | Instrumentation Industries, Inc. | 1981-07-21 |