SCITECH BI-MANUAL ADAPTER CLIPS
FDA 510(k) clearance K910088 · decided 1991-04-08
Clearance details
- K-number
- K910088
- Device name
- SCITECH BI-MANUAL ADAPTER CLIPS
- Applicant
- Scitech Industries Partnership
- Decision
- Substantially Equivalent
- Date received
- 1991-01-09
- Decision date
- 1991-04-08
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- HQQ
- Device class
- 2
- Regulation number
- 886.4100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Woodcliff Lake, NJ, 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 |
|---|---|---|
| MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (K903878) | Mentor O & O, Inc. | 1990-11-05 |
| MENTOR WET-FIELD*II COAGULATOR (K881001) | Mentor O & O, Inc. | 1988-05-13 |
Recalls involving this device
No recalls on record reference this clearance.