510(k) K760927
- Device
- STOMA SHIELD ADAPTER
- Applicant
- Rudolfo T. Sanchez
- 510(k) number
- K760927
- Product code
- EXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-26
- Date received
- 1976-10-28
- Regulation
- 876.5900
- Classification name
- Protector, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- 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#
- 8022978
- 3015332213
- 3015821396
- 3034669683
- 3017448136
- 2320961
- 3015414875
- 8040278
- 3011814545
- 3006131984
- 3008806809
- 1000317571
- 3006358042
- 3031582434
- 3027517726
- 3014666579
- 3012034017
- 3009655869
- 3016426850
- 2530957
- 3011987967
- 3003348807
- 3013564290
- 3002807315
- 3006121457
- 3011247798
- 3011191255
- 3008244559
- 3015865915
- 3012421607
- 3015140210
- 3011558220
- 3030733800
- 1058584
- 3013557562
- 3011689956
- 3006787036
- 1119193
- 3016675012
- 1220581
- 3013530901
- 3003902312
- 3013180212
- 3012465068
- 3014579161
- 3006609021
- 3015300984
- 3013863160
- 3008432385
- 3007417132
- 1480288
- 3027514586
- 3004610510
- 3014195785
- 3021632375
- 9618003
- 3012706495
- 3010372554
- 3015140199
- 3013298431
- 9710641
- 3011270181
- 3012502601
- 2023344
- 3015142802
- 3016452400
- 9681410
- 3007441619
- 3030446844
- 3030226295
- 3016758972
- 3010580321
- 3011495142
- 3014461810
- 3014404707
- 3031184338
- 1225157
Source Documents#
510(k) summary PDF not indicated by FDA