FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K Number: K964620
·
Decision Jan 9, 1997
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
2
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PANOGAUZE NON-WOVEN HYDROGEL DRESSING
- K Number
- K964620
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Sage Pharmaceuticals, Inc.
- Date Received
- November 18, 1996
- Decision Date
- January 9, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGQ), ordered by most recent decision date.
HylaGuard Moisturizing Cream
FDA 510(k)
FDA Unclassified
·Unknown
HYLATOPIC EMOLLIENT FOAM
FDA 510(k)
FDA Unclassified
·Unknown
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSITE OR CALGITROL
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSEAL
FDA 510(k)
FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Sage Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945005 | PANOPLEX HYDROGEL WOUND DRESSING | Mar 24, 1995 | Substantially Equivalent |