FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
K Number: K974520
·
Decision Feb 6, 1998
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
- K Number
- K974520
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Technologies (Us), Inc.
- Date Received
- December 2, 1997
- Decision Date
- February 6, 1998
- Product Code
- MGP
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
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