FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUA-GARD WATERPROOF WOUND PATCH
K Number: K905022
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
3
Review Days
96
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Basic Information
- Device Name
- AQUA-GARD WATERPROOF WOUND PATCH
- K Number
- K905022
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bellhouse Medical, Inc.
- Date Received
- November 7, 1990
- Decision Date
- February 11, 1991
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
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