LITHOTOMY CHAIR #415
FDA 510(k) clearance K831385 · decided 1983-06-02
Clearance details
- K-number
- K831385
- Device name
- LITHOTOMY CHAIR #415
- Applicant
- Midmark Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-28
- Decision date
- 1983-06-02
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- GBB
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| TENET TIBIAL FRACTURE SUPPORT (K964102) | Tenet Medical Engineering | 1996-12-05 |
| HYDRAULIC FOOT OPERATED STOOL (K893598) | Arthro-Medic, Inc. | 1989-10-10 |
| NUTROMAT (K831325) | Medlog GmbH Marketing Services | 1983-06-02 |
| NAGASHIMA SN OPERATOR'S CHAIR (K822264) | Kelleher Corp. | 1982-10-13 |
| EXAMINATION & TREATMENT CHAIRS (K822251) | Kelleher Corp. | 1982-08-27 |
| NAGASHIMA SN AUTOMATIC TREATMENT CHAIR (K822013) | Kelleher Corp. | 1982-07-28 |
| STORZ #6500 POWER EXAMINATION CHAIR (K820636) | Storz Instrument Co. | 1982-03-26 |
Recalls involving this device
No recalls on record reference this clearance.