FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR
K Number: K932333
·
Decision Aug 15, 1995
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
57
Review Days
824
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Basic Information
- Device Name
- PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR
- K Number
- K932333
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gull Laboratories, Inc.
- Date Received
- May 13, 1993
- Decision Date
- August 15, 1995
- Product Code
- EFB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Oct 5, 1992 | Substantially Equivalent |
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