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#
- 3015989060
- 3009307523
- 3016680721
- 3014601456
- 3017041963
- 3005271071
- 3009443860
- 3012344767
- 3008252907
- 3010160370
- 1422598
- 3017486862
- 3015960676
- 3030089808
- 3008518409
- 3010934856
- 3008808123
- 3005022483
- 3013006775
- 9615270
- 3045077467
- 3017840934
- 3008559312
- 3038138497
- 3008427684
- 3016758972
- 9614306
- 1417592
- 3007517215
- 3007710677
- 3013260641
- 3008008970
- 9680934
- 3010359088
- 3013026943
- 9615551
- 3008756535
- 3006550126
- 3012267116
- 3011434305
- 1043644
- 3010141571
- 1055823
- 3010598169
- 2022409
- 3010162721
- 9611326
- 9680357
- 3012841710
- 3043049733
- 2183301
- 3003495693
- 3010621964
- 2437780
- 3033588963
- 3017406840
- 1000358138
- 3014683120
- 3037040712
- 3007407626
- 9617805
- 3017461134
- 3002957587
- 3011587065
- 3009716062
- 1053445
- 3006535976
- 1527185
- 3009542933
- 3005246188
- 3004362278
- 3011545608
- 3011707926
- 3008959420
- 3011276959
- 2182318
- 3000126234
- 3016763307
- 3011270181
- 3017364709
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 |