SURGICAL CAP
FDA 510(k) clearance K954556 · decided 1996-03-12
Clearance details
- K-number
- K954556
- Device name
- SURGICAL CAP
- Applicant
- Thai Disposable Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-02
- Decision date
- 1996-03-12
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FYF
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Samutprakaran, TH
- 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 |
|---|---|---|
| SHOE COVER (K972227) | American Seal Co. | 1997-09-09 |
| NIOMED SURGICAL CAPS (K955833) | Amerasia Corp. | 1996-03-15 |
| NIOMED SURGICAL HOOD (K954454) | Amerasia Corp. | 1996-01-23 |
| NIOMED BOUFFANT CAPS (K954455) | Amerasia Corp. | 1996-01-23 |
| SURGEON'S CAP (K953879) | American Threshold Industries, Inc. | 1996-01-05 |
| BOUFFANT CAP (K953878) | American Threshold Industries, Inc. | 1996-01-05 |
| DISPOSABLE BOUFFANT CAP (K913700) | Gem Nonwovews, Inc. | 1991-10-04 |
| INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (K882346) | Nordbye, Milchman, Barlage | 1988-06-30 |
| SURGEONS CAP (K882284) | A Plus International, Inc. | 1988-06-23 |
| BOUFFANT CAP (K882283) | A Plus International, Inc. | 1988-06-23 |
| CARETEX SURGEON'S CAPS (K880481) | James River Corp. | 1988-02-24 |
| KIMBERLY-CLARK FULL COVERAGE HOOD (K875261) | Kimberly-Clark Corp. | 1988-01-22 |
Recalls involving this device
No recalls on record reference this clearance.