FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
SPYROGEL WOUND DRESSING
K Number: K932457
·
Decision Feb 9, 1994
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
5
Review Days
264
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Basic Information
- Device Name
- SPYROGEL WOUND DRESSING
- K Number
- K932457
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Polymint Industrial Co. , Ltd.
- Date Received
- May 21, 1993
- Decision Date
- February 9, 1994
- 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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