FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
K Number: K915207
·
Decision Feb 14, 1992
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
2
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
- K Number
- K915207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6300
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bay Technical Products, Inc.
- Date Received
- November 18, 1991
- Decision Date
- February 14, 1992
- Product Code
- EEF
- 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 |
|---|---|---|---|
| EEF | Clamp, Rubber Dam | FDA class 1 | Dental |
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