510(k) K883023
- Device
- MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
- Applicant
- MENTOR CORP.
- 510(k) number
- K883023
- Product code
- GDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-29
- Date received
- 1988-07-19
- Regulation
- 876.5900
- Classification name
- Bag, Stomal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN BRECKENRIDGE
- Address
- 600 Pine Ave. Goleta CA US 93117 93117
FDA Registration Numbers#
- 3031289255
- 3013530901
- 3042251637
- 3009167225
- 3014666579
- 3006621348
- 1450662
- 3017448136
- 3011495142
- 1424263
- 1480288
- 2320961
- 3010521050
- 3035375032
- 1119193
- 3015142802
- 1047843
- 3014421917
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871313 | ULTRA-FRESH DEODORANT | Mentor Corp. | 1988-03-02 |
Legacy Summary#
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FDA Review#
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