FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODYNE INSTRUMENT WIPES
K Number: K900691
·
Decision Mar 8, 1990
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
3
Review Days
23
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Basic Information
- Device Name
- BIODYNE INSTRUMENT WIPES
- K Number
- K900691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Bio-Dyne, Inc.
- Date Received
- February 13, 1990
- Decision Date
- March 8, 1990
- Product Code
- GEC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | FDA class 1 | General, Plastic Surgery |
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