FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EPITECH ISLAND DRESSINGS
K Number: K971337
·
Decision Jul 9, 1997
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- EPITECH ISLAND DRESSINGS
- K Number
- K971337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rynel, Ltd. Inc.
- Date Received
- April 10, 1997
- Decision Date
- July 9, 1997
- Product Code
- KMF
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Rynel, Ltd. Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951909 | RYNEL MEDICAL FOAM | Jun 21, 1995 | Substantially Equivalent |