510(k) K761069
- Device
- P.S.M. BOTIQUE CAP
- Applicant
- The Owenby Co.
- 510(k) number
- K761069
- 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#
- 3010625818
- 3004513970
- 3004158259
- 3009540572
- 3011547453
- 3008311433
- 3005728058
- 3014146451
- 3010598169
- 3012034017
- 3016622475
- 3009282549
- 3034669683
- 3008887731
- 3011298394
- 3001124136
- 3006942361
- 9680357
- 9680222
- 3005748481
- 3033507138
- 1933975
- 3010155681
- 3016426842
- 3005090771
- 2022409
- 3038718579
- 3009233038
- 9616875
- 9616096
- 3011529314
- 3016714803
- 9614075
- 3043049733
- 3007479164
- 3029802606
- 3006123105
- 3015167798
- 3017235663
- 3013260641
- 3018490301
- 3012207247
- 3017450342
- 3008240985
- 3011140825
- 3038356900
- 3043749706
- 3011497662
- 1423537
- 3009716062
- 3023435669
- 3014421917
- 3013410562
- 3003495693
- 2433012
- 3008500638
- 3043051314
- 3010162721
- 3004998166
- 9611959
- 3008466086
- 3004105221
- 9613910
- 3017103765
- 3015960676
- 3025771437
- 3006982954
- 3014167550
- 3034226814
- 3017408377
- 3004133257
- 3008489813
- 3014273597
- 3015495690
- 8030607
- 3013269506
- 3008808560
- 3011526299
- 3013496867
- 3017953189
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 |