510(k) K761340
- Device
- OSTOMY KARAYA GUM POWDER
- Applicant
- Howmedica Corp.
- 510(k) number
- K761340
- Product code
- EZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-07
- Date received
- 1976-12-28
- Regulation
- 876.5900
- Classification name
- Cement, Stomal Appliance, 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#
- 3030733800
- 1417592
- 3003348807
- 3008244559
- 3008374791
- 3012465068
- 3000268902
- 3011987967
- 1480288
- 3016615875
- 1450819
- 1000317571
- 3007417132
- 3013530901
- 3013557562
- 3011495142
- 2023344
- 3016761372
- 3001124136
- 1119193
- 3011689956
- 3012502601
- 3013863160
- 3038718579
- 3014579161
- 9618003
- 3016426850
- 2320961
- 3008806809
- 3013298431
- 2530957
- 3006784948
- 3030446844
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EZR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844341 | UNITED SKIN BARRIER PASTE | Howmedica Corp. | 1985-01-18 |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | E. R. Squibb & Sons, Inc. | 1981-01-08 |
| K791146 | COLO-TAPE | Suburban Ostomy Supply Co., Inc. | 1979-07-30 |
| K770230 | KARAYA GUM POWDER | Atlantic Surgical | 1977-02-28 |
| K761319 | KARAYA GUM PRODUCTS - PROCESS CHANGE | Howmedica Corp. | 1977-02-15 |