UNNA-SLEEVE(TM)
FDA 510(k) clearance K903532 · decided 1990-11-02
Clearance details
- K-number
- K903532
- Device name
- UNNA-SLEEVE(TM)
- Applicant
- Aci Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-06
- Decision date
- 1990-11-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LLK
- Device class
- 2
- Regulation number
- 880.5780
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sun Valley, CA, 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 |
|---|---|---|
| TECNOL COMPRESSION KNEE DRESSING (K873368) | Tecnol New Jersey Wound Care, Inc. | 1987-12-11 |
| COMPRESSION LEGGING DEVICE (K871889) | A-T Surgical Mfg. Co., Inc. | 1987-08-04 |
| MODEL 1888 ALPHA COS/RESPIRATION CAR (K834460) | Spacelabs, Inc. | 1984-02-13 |
Recalls involving this device
No recalls on record reference this clearance.