COMPRESSOGRIP ELASTIC STUMP SHRINKER#
FDA 510(k) clearance K831540 · decided 1983-06-08
Clearance details
- K-number
- K831540
- Device name
- COMPRESSOGRIP ELASTIC STUMP SHRINKER#
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-12
- Decision date
- 1983-06-08
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- ILG
- Device class
- 1
- Regulation number
- 890.3475
- 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 |
|---|---|---|
| ORTHOPEDIC STOCKINETTE (K833437) | Northern Medical Surgical, Inc. | 1983-11-03 |
| STOCKINETTE, STERILE (K780612) | Abco Dealers, Inc. | 1978-04-19 |
| STERILE ORTHOPEDIC STOCKINETTE (K780547) | Alba-Waldensian, Inc. | 1978-04-10 |
| ORTHOPEDIC STOCKINETTE (K770346) | Convertors | 1977-03-07 |
| STOCKINETTE (K770173) | Chase Mfg. Co. | 1977-02-08 |
| ORTHOPEDIC TUBULAR STOCKINETTE (K760817) | Parke-Davis Co. | 1976-10-20 |
| TOURNIWRAP BANDAGE (K760576) | Richard'S Medical Equip., Inc. | 1976-10-05 |
Recalls involving this device
No recalls on record reference this clearance.