510(k) K770260
- Device
- CAP, CLARION NURSES OR (TECHNIC)
- Applicant
- SHERWOOD MEDICAL INDUSTRIES
- 510(k) number
- K770260
- Product code
- FYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-07
- Date received
- 1977-02-12
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011545608
- 3023339277
- 3010598169
- 3015432501
- 3013528379
- 3019848304
- 3014273597
- 3013823570
- 3018490301
- 3016622475
- 3012344767
- 3004105221
- 3005748481
- 3021247124
- 9680934
- 3017408377
- 3015416207
- 3005271071
- 3008240985
- 3004133257
- 3017231740
- 3016741939
- 3017450342
- 3015625160
- 3037040712
- 9613910
- 3009655869
- 3023435669
- 3045058049
- 9680794
- 1530671
- 3010155681
- 3011547453
- 3006550126
- 3009542933
- 3044026004
- 3008494033
- 3005090771
- 3010626683
- 3010162721
- 3006437555
- 3019458442
- 3043051314
- 3006942361
- 3007029063
- 3030678923
- 3013530901
- 3011707926
- 3033588963
- 1422598
- 3016746538
- 3016989300
- 3010147274
- 3008559312
- 3014683120
- 1933975
- 3008466086
- 9680222
- 3016170492
- 3013260641
- 3016758972
- 3031184338
- 3034226814
- 3005621808
- 3016457665
- 3017406840
- 3030067857
- 3010141571
- 3004488394
- 3004753358
- 3008959420
- 3008887731
- 3006973666
- 3013410562
- 2248180
- 3009307523
- 3008311433
- 3011497662
- 3016426851
- 3033507138
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 |
Legacy Summary#
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FDA Review#
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