510(k) K760954
- Device
- CROWNTEX EXAM. CAPE & GOWN
- Applicant
- Graham Manufacturing Co.
- 510(k) number
- K760954
- Product code
- FME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-30
- Date received
- 1976-11-02
- Regulation
- 880.6265
- Classification name
- Gown, Examination
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3010131137
- 3010656982
- 2183301
- 3010934856
- 3016874083
- 3007710677
- 3006942361
- 3015526463
- 3008808123
- 3017408377
- 2027804
- 3006535976
- 3045058049
- 3038138497
- 3031184338
- 3037040712
- 3015068387
- 3038131022
- 3011497662
- 3033588963
- 3010141571
- 3004127972
- 3010595915
- 3008663306
- 3006123105
- 2432177
- 3015219076
- 3006891803
- 3015997711
- 3023435669
- 3008466086
- 3008381089
- 3023339277
- 3008008970
- 3010014065
- 3010621964
- 3005841027
- 3015058854
- 3004105221
- 3004998166
- 2648727
- 3006582165
- 1933975
- 3013123550
- 3011529314
- 3010359088
- 3006400329
- 3013427445
- 1422598
- 3016970619
- 3010198795
- 3034669683
- 3016096058
- 9614306
- 3013260641
- 3009540572
- 1053445
- 3013440654
- 3016758972
- 1055823
- 3013960812
- 3012034017
- 3017953189
- 3017461111
- 3015140351
- 3008252907
- 3017406840
- 3034629649
- 3026222938
- 3027327527
- 3038772401
- 1417592
- 3006538071
- 3012841710
- 3017417635
- 3011434305
- 3017865197
- 9681151
- 3007175977
- 2086890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FME#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET | Kimberly-Clark Corp. | 1988-02-19 |
| K811915 | MONITOR/VITAL SIGNS TRAY | American Hospital Supply Corp. | 1981-07-28 |
| K770476 | EXAM GOWN | General Medical Co. | 1977-05-06 |
| K760360 | SHIRT, MITTEN CUFF INFANT | Precept, Inc. | 1976-10-20 |