SKYTRON ELITE 300 SURGERY TABLE
FDA 510(k) clearance K853479 · decided 1985-09-05
Clearance details
- K-number
- K853479
- Device name
- SKYTRON ELITE 300 SURGERY TABLE
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-20
- Decision date
- 1985-09-05
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- FWW
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Grand Rapids, 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 |
|---|---|---|
| OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (K953961) | Osteonics Corp. | 1995-11-29 |
| CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (K935356) | Amsco American Sterilizer Co. | 1994-03-23 |
| FISK ARM SUPPORT (K931876) | Vvortex International Corp. | 1993-09-09 |
| UNIVERSAL SURGICAL INSTRUMENT HOLDER (K924713) | T. Korossurgical Instruments Corp. | 1993-05-17 |
| TABLE, OPERATING ROOM, HYDRAULIC (K863161) | Kamiya Tsusan Kaisha, Ltd. | 1986-09-05 |
Recalls involving this device
No recalls on record reference this clearance.