FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROFAST(R)-DENTURE ADHESIVE CREAM
K Number: K930336
·
Decision Aug 24, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
12
Applicant Total
3
Review Days
214
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Basic Information
- Device Name
- PROFAST(R)-DENTURE ADHESIVE CREAM
- K Number
- K930336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5570
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fittydent-Altwirth & Schmitt GmbH
- Date Received
- January 22, 1993
- Decision Date
- August 24, 1993
- Product Code
- KGB
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | FDA class 1 | Anesthesiology |
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