DEROYAL DRAPES, STERILE, NON-STERILE
FDA 510(k) clearance K030365 · decided 2003-04-29
Clearance details
- K-number
- K030365
- Device name
- DEROYAL DRAPES, STERILE, NON-STERILE
- Applicant
- Deroyal Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-04
- Decision date
- 2003-04-29
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Powell, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #99 recall (Z-1490-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |
| Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72. recall (Z-1491-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |
| Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, # recall (Z-1492-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |
| Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', recall (Z-1493-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |
| Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Re recall (Z-1494-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |
| Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60 recall (Z-1495-04) | Deroyal Surgical -Rose Hill | 2004-09-29 |