ALGOPLAQUE HYDROCOLLOID DRESSING
FDA 510(k) clearance K970518 · decided 1997-03-21
Clearance details
- K-number
- K970518
- Device name
- ALGOPLAQUE HYDROCOLLOID DRESSING
- Applicant
- Laboratoires Urgo S.A.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-02-11
- Decision date
- 1997-03-21
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.