FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
HYDROSKIN WOUND DRESSING
K Number: K942815
·
Decision Jul 11, 1994
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
2
Review Days
26
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Basic Information
- Device Name
- HYDROSKIN WOUND DRESSING
- K Number
- K942815
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Hymedix Intl., Inc.
- Date Received
- June 15, 1994
- Decision Date
- July 11, 1994
- 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 Hymedix Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942419 | HYDRO-S WOUND GEL | Aug 5, 1994 | Substantially Equivalent |