FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K Number: K935203
·
Decision Jan 18, 1994
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
- K Number
- K935203
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Renaissance Medical, Inc.
- Date Received
- October 26, 1993
- Decision Date
- January 18, 1994
- Product Code
- MGQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
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