HANDLES, LIGHT, SURGICAL, STEOILE
FDA 510(k) clearance K770812 · decided 1977-05-23
Clearance details
- K-number
- K770812
- Device name
- HANDLES, LIGHT, SURGICAL, STEOILE
- Applicant
- Sybron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-03
- Decision date
- 1977-05-23
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- FQP
- Device class
- 2
- Regulation number
- 878.4580
- 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 |
|---|---|---|
| ACULUX, MODEL AX3001, AX3002 (K001223) | Aculux | 2000-06-23 |
| SYNTHES LIGHT GUIDE (K993314) | Synthes (Usa) | 1999-12-06 |
| SURGICAL LIGHT 22 SERIES (K781581) | American Sterilizer Co. | 1978-10-17 |
| SURGICAL LIGHT - CHALLENGE 22 SERIES (K761018) | Amsco Co. | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.