TRIANGULAR BANDAGE CAT.#191
FDA 510(k) clearance K802006 · decided 1980-09-16
Clearance details
- K-number
- K802006
- Device name
- TRIANGULAR BANDAGE CAT.#191
- Applicant
- Pollak (Intl.), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-20
- Decision date
- 1980-09-16
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- ILI
- Device class
- 1
- Regulation number
- 890.3640
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| MATRX, PYRAMID TRIANGLE BANDAGE (K912661) | Matrix Medica, Inc. | 1991-08-21 |
| ARM SLINGS (K831549) | Fred Sammons, Inc. | 1983-06-30 |
| SATO FAMILY FIRST AID KIT (K831706) | Food and Drug Service, Inc. | 1983-06-24 |
| VARIOUS ARM SLING (K823808) | Danek Medical, Inc. | 1983-01-14 |
| A.C. SPLINT (K823810) | Danek Medical, Inc. | 1983-01-14 |
| UNIVERSAL SLING, SLING & SWATHE (K823664) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| UNIVERSAL SLING, SLING & SWATHE (K823162) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| ORTHOPEDIC SOFT GOODS (K820590) | Abco Dealers, Inc. | 1982-03-26 |
| ARM SLING, POUCH TYPE (K812477) | Maddak, Inc. | 1981-09-14 |
| MADDACOMFORT SLING (K812478) | Maddak, Inc. | 1981-09-14 |
| LIMB HOLDER ARM SLING (K812480) | Maddak, Inc. | 1981-09-14 |
| ARM SLINGS (K812345) | Fred Sammons, Inc. | 1981-09-11 |
Recalls involving this device
No recalls on record reference this clearance.