FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
MEDI GUARD DRAPES
K Number: K911950
·
Decision May 21, 1991
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
5
Review Days
20
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Basic Information
- Device Name
- MEDI GUARD DRAPES
- K Number
- K911950
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sancella, Inc.
- Date Received
- May 1, 1991
- Decision Date
- May 21, 1991
- 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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