510(k) K882346
- Device
- Instrument Protect-a-caps, Aka: Tip/instru. Guard
- Applicant
- NORDBYE, MILCHMAN, BARLAGE
- 510(k) number
- K882346
- Product code
- FYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-30
- Date received
- 1988-06-07
- 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
- No
Applicant Contact#
- Contact
- KAY NORDBYE
- Address
- Yorktown Executive Suites 7101 York Ave. S Edina MN US 55435 55435
FDA Registration Numbers#
- 3012761602
- 1043646
- 3019458442
- 1530671
- 3010595009
- 3044150131
- 3014146451
- 3011298394
- 3009307523
- 3001124136
- 3006538071
- 3006942361
- 3015391081
- 3009233038
- 3003965134
- 3011547453
- 3023435669
- 3016096096
- 3009834955
- 3016457665
- 3010141571
- 3009540572
- 3034629649
- 3038276119
- 3003495693
- 3017103765
- 3014167550
- 3008311433
- 3024787345
- 3031582434
- 3012034017
- 3004158259
- 3005327291
- 3013527364
- 3009489102
- 3014683120
- 3008663306
- 3010353405
- 3010583458
- 3013496867
- 3034226814
- 2433012
- 3015960676
- 3016763307
- 3008466086
- 9614075
- 3017194442
- 3012267116
- 3033511100
- 3016426842
- 3030067857
- 1422598
- 3005841027
- 3014620201
- 3008240985
- 3017406840
- 9680794
- 3005728058
- 3007517215
- 3008887731
- 3043049733
- 3011066276
- 3021486363
- 2022409
- 3016994953
- 3011210208
- 3002722429
- 3017597597
- 3043749706
- 3033507138
- 3017952343
- 3006943846
- 3009596133
- 3014437893
- 3016649599
- 3014666579
- 3016686946
- 3009282549
- 3016622475
- 3017450342
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 |
| 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 |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Greene International Corp. | 1987-03-09 |