STERILE/DISPOSABLE HSG TRAY
FDA 510(k) clearance K810291 · decided 1981-03-18
Clearance details
- K-number
- K810291
- Device name
- STERILE/DISPOSABLE HSG TRAY
- Applicant
- Unimar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-03
- Decision date
- 1981-03-18
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- EYY
- Device class
- 2
- Regulation number
- 878.4370
- 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 |
|---|---|---|
| THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE (K851675) | Lingeman Medical Products, Inc. | 1985-05-14 |
Recalls involving this device
No recalls on record reference this clearance.