510(k) K761068
- Device
- P.S.M. BOUFFANT CAP
- Applicant
- The Owenby Co.
- 510(k) number
- K761068
- Product code
- FYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-30
- Date received
- 1976-11-16
- Regulation
- 878.4040
- Classification name
- Cap, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3016989300
- 3010595009
- 3014314985
- 9615909
- 3006644649
- 3009307523
- 3038356900
- 3014601456
- 3017041963
- 3006437555
- 3005271071
- 3043648115
- 3012344767
- 3010160370
- 1422598
- 3011526299
- 3004488394
- 3015960676
- 3008352964
- 3004361903
- 3013006775
- 9615270
- 3017212217
- 3018020588
- 2248180
- 3017419584
- 3017840934
- 3043749706
- 3008559312
- 3008500638
- 3003890648
- 3016758972
- 9614306
- 1417592
- 3017692139
- 3007517215
- 3013260641
- 9680934
- 1423537
- 3008756535
- 3010626683
- 3020048546
- 3005599545
- 3012267116
- 3011298394
- 3006550126
- 3004513970
- 3010141571
- 3014437893
- 3010598169
- 2022409
- 3030678923
- 3004753358
- 3007165189
- 3010162721
- 3013530901
- 3016457665
- 8043467
- 9611959
- 3014167550
- 9680357
- 3043049733
- 3015495690
- 9680222
- 3003495693
- 3010621964
- 3044150131
- 3033588963
- 3008770063
- 3017406840
- 3014683120
- 3037040712
- 3007407626
- 3011587065
- 3009716062
- 3042228024
- 3030220356
- 3009542933
- 3014312726
- 3004362278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972227 | SHOE COVER | American Seal Co. | 1997-09-09 |
| K955833 | NIOMED SURGICAL CAPS | Amerasia Corp. | 1996-03-15 |
| K954556 | SURGICAL CAP | Thai Disposable Products Co., Ltd. | 1996-03-12 |
| K954454 | NIOMED SURGICAL HOOD | Amerasia Corp. | 1996-01-23 |
| K954455 | NIOMED BOUFFANT CAPS | Amerasia Corp. | 1996-01-23 |
| K953878 | BOUFFANT CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K953879 | SURGEON'S CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K913700 | DISPOSABLE BOUFFANT CAP | Gem Nonwovews, Inc. | 1991-10-04 |
| K882346 | INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD | Nordbye, Milchman, Barlage | 1988-06-30 |
| K882283 | BOUFFANT CAP | A Plus International, Inc. | 1988-06-23 |
| K882284 | SURGEONS CAP | A Plus International, Inc. | 1988-06-23 |
| K880481 | CARETEX SURGEON'S CAPS | James River Corp. | 1988-02-24 |
| K875261 | KIMBERLY-CLARK FULL COVERAGE HOOD | Kimberly-Clark Corp. | 1988-01-22 |
| K874066 | SURGICAL CAPS | Interpro Intl., Inc. | 1987-11-04 |
| K873830 | TECNOL SURGEON'S CAP | Tecnol New Jersey Wound Care, Inc. | 1987-10-23 |