FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
K Number: K883023
·
Decision Sep 29, 1988
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
1
Applicant Total
61
Review Days
72
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Basic Information
- Device Name
- MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
- K Number
- K883023
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mentor Corp.
- Date Received
- July 19, 1988
- Decision Date
- September 29, 1988
- Product Code
- GDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GDS | Bag, Stomal | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
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