VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42
FDA 510(k) clearance K851108 · decided 1985-04-25
Clearance details
- K-number
- K851108
- Device name
- VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42
- Applicant
- The Huxley Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-19
- Decision date
- 1985-04-25
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Penn Yan, NY, US
- Third-party review
- No
- Expedited review
- No
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| MRI FASTSYSTEM RETRACTOR SYSTEM (K001339) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
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| VILLALTA RETRACTOR (K943875) | Hct, Inc. | 1994-11-09 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| RETRACTOR (K941448) | Technovations | 1994-04-15 |
Recalls involving this device
No recalls on record reference this clearance.