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#
- 3015173212
- 3010653892
- 2182318
- 3015288041
- 3016685880
- 3002637602
- 3013410562
- 3012911667
- 2032476
- 3002957587
- 9681151
- 9615551
- 3034669683
- 3016450032
- 3013440654
- 3010162721
- 3012267116
- 3013006775
- 3034629649
- 9611326
- 3013427445
- 3017398283
- 3006897996
- 3004127972
- 3004967902
- 3012841710
- 3011434305
- 3010147274
- 3011707926
- 3006113262
- 3017417635
- 3009443860
- 9680357
- 3015526463
- 3008311433
- 3008808123
- 3015997711
- 1054380
- 3003495693
- 2027804
- 3008191396
- 9617805
- 3006798117
- 3007710677
- 3030645716
- 3011529314
- 3008252907
- 3011091529
- 3016758972
- 3005022483
- 3030432749
- 3011556876
- 3008518409
- 3009233038
- 3016452400
- 3012034017
- 3023435669
- 9614306
- 1640425
- 3016763307
- 2432177
- 3008008970
- 3019848304
- 3004160996
- 3007479164
- 3007050292
- 3017408377
- 3005327291
- 3017840934
- 3021286079
- 3006123105
- 3008856821
- 1422598
- 2087200
- 2024980
- 2022409
- 3012761602
- 3023339277
- 3014601456
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 |