SPYROFLEX WOUND DRESSING
FDA 510(k) clearance K953618 · decided 1995-08-21
Clearance details
- K-number
- K953618
- Device name
- SPYROFLEX WOUND DRESSING
- Applicant
- Polymedica Industries, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-08-03
- Decision date
- 1995-08-21
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Golden,, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.