FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
SPYROGEL HYDROGEL WOUND AND BURN DRESSING
K Number: K982804
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
3
Review Days
128
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Basic Information
- Device Name
- SPYROGEL HYDROGEL WOUND AND BURN DRESSING
- K Number
- K982804
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Innovative Technologies (Us), Inc.
- Date Received
- August 10, 1998
- Decision Date
- December 16, 1998
- 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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