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#
- 3015173212
- 3006799943
- 3010653892
- 1423537
- 3014273597
- 3016685880
- 9680887
- 3007048057
- 3034602341
- 3016686946
- 3033011342
- 1530671
- 3013410562
- 9681151
- 3034669683
- 3013440654
- 3010162721
- 3012267116
- 3013388519
- 3005621808
- 3012268821
- 3007165189
- 3007289408
- 3014257280
- 3038632739
- 3019458442
- 3013006775
- 3034629649
- 3030678923
- 3006897996
- 3004998166
- 3011424870
- 3010147274
- 3011707926
- 3006113262
- 3008770063
- 9680357
- 3015526463
- 3008311433
- 3031582434
- 3009489102
- 3003495693
- 9613910
- 3030067857
- 3005599545
- 2433012
- 3043648115
- 3011529314
- 3016758972
- 3014666579
- 3033848619
- 8030654
- 3001650535
- 3009233038
- 3016452400
- 3012034017
- 3023435669
- 3005558160
- 3013502418
- 3014314985
- 9614306
- 3018490301
- 3016994953
- 3017846745
- 3016763307
- 3017597597
- 3017212217
- 3019848304
- 3016989300
- 3014167550
- 9611959
- 3007479164
- 3017408377
- 3005327291
- 3016426842
- 3017840934
- 3042228024
- 3006123105
- 1422598
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 |
| K954455 | NIOMED BOUFFANT CAPS | Amerasia Corp. | 1996-01-23 |
| K954454 | NIOMED SURGICAL HOOD | Amerasia Corp. | 1996-01-23 |
| K953879 | SURGEON'S CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K953878 | BOUFFANT CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K913700 | DISPOSABLE BOUFFANT CAP | Gem Nonwovews, Inc. | 1991-10-04 |
| K882284 | SURGEONS CAP | A Plus International, Inc. | 1988-06-23 |
| K882283 | BOUFFANT 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 |
| K870618 | VARIOUS TYPES OF SURGICAL GARMENTS | Kin Yuh Hung Co., Ltd. | 1987-03-09 |