FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
BIO-GUARD SHAVE PREP TRAY
K Number: K905003
·
Decision Dec 28, 1990
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- BIO-GUARD SHAVE PREP TRAY
- K Number
- K905003
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Network Medical Systems, Inc.
- Date Received
- November 7, 1990
- Decision Date
- December 28, 1990
- Product Code
- KME
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
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