TRAY DOUGH
FDA 510(k) clearance K911225 · decided 1991-04-17
Clearance details
- K-number
- K911225
- Device name
- TRAY DOUGH
- Applicant
- The Hygenic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-21
- Decision date
- 1991-04-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KGS
- Device class
- 1
- Regulation number
- 878.4930
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
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| ACUFEX ROTATOR CUFF FIXATION BUTTON (K941740) | Acufex Microsurgical, Inc. | 1995-06-30 |
| MITEK CONE WASHER (K930675) | Mitek Surgical Products, Inc. | 1993-11-09 |
| VENTROFIL TENSION RELIEF SUTURE SET (K904435) | Aesculap, Inc. | 1991-08-29 |
| SUTURE TENSION ADJUSTMENT REEL (K904136) | Surgical Systems, Inc. | 1990-10-02 |
| SURGICAL RETENTION BAR (K902001) | Acufex Microsurgical, Inc. | 1990-05-09 |
| ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (K896310) | Acufex Microsurgical, Inc. | 1989-11-20 |
| DERMACARE TIE HOLDER (K893995) | Dermacare | 1989-08-11 |
| ACUFEX FIXATION BUTTON (K884565) | Acufex Microsurgical, Inc. | 1989-02-27 |
| SUTURE RETENTION DEVICE (K883299) | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 |
Recalls involving this device
No recalls on record reference this clearance.