FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ROYL-DERM WOUND HYDROGEL DRESSING
K Number: K932973
·
Decision Jan 10, 1994
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
4
Review Days
210
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Basic Information
- Device Name
- ROYL-DERM WOUND HYDROGEL DRESSING
- K Number
- K932973
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Renaissance Medical, Inc.
- Date Received
- June 14, 1993
- Decision Date
- January 10, 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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