510(k) K912790
- Device
- SURGICAL GOWN
- Applicant
- Unicor Federal Dept. of Justice
- 510(k) number
- K912790
- Product code
- FYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-19
- Date received
- 1991-06-25
- Regulation
- 878.4040
- Classification name
- Dress, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A.DIXON
- Address
- Fed.Corectional Institution Alderson WV US 24910 24910
FDA Registration Numbers#
- 3007123908
- 3010626683
- 3002957587
- 3035523371
- 3006943846
- 3031582449
- 3006437555
- 3016680721
- 8043817
- 3012101664
- 3008856821
- 3008868758
- 3015288041
- 3043049733
- 3016989300
- 3015173212
- 3013894805
- 3033511100
- 3004519921
- 3012344767
- 3023141635
- 3013006775
- 3008339799
- 3008044603
- 3016195240
- 3015068387
- 3037040712
- 3013426279
- 3003965134
- 3002769844
- 3017235663
- 3016994953
- 1928237
- 3006973666
- 3005343641
- 3015341499
- 3014257280
- 3012421607
- 1423395
- 3011526299
- 3015516266
- 3003835287
- 2086043
- 3017103765
- 3005327291
- 3016741939
- 3009486864
- 3005090771
- 3006847952
- 3011529314
- 3005012805
- 3013528379
- 1058584
- 3016763307
- 3006210673
- 3006636961
- 1933975
- 3009540572
- 1818910
- 9615551
- 3013530901
- 2244900
- 3013580507
- 3010353405
- 3004046477
- 3038632739
- 3016457665
- 3009489102
- 3015167798
- 3017212217
- 3011310668
- 3004127972
- 3021023132
- 3008427684
- 9611590
- 3014620201
- 1319130
- 2518423
- 3008489813
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932731 | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN | Johnson & Johnson Medical, Inc. | 1994-04-11 |
| K910920 | PROTEKT GLOVES | Intermedics Orthopedics | 1991-05-15 |
| K910941 | LIFELINER SURGICAL GLOVE | Depuy-Raynham | 1991-05-09 |
| K895667 | STERILE SURGICAL GOWN | Clinitech, Inc. | 1989-10-13 |
| K895235 | VARIOUS DISPOSABLE SURGICAL GARMENTS | Protect Corp. of Indiana, Inc. | 1989-09-19 |
| K894760 | CLOTHINGUARD | Barrier Concepts, Inc. | 1989-08-18 |