510(k) K974348
K974348 is an FDA 510(k) premarket notification submitted by Laboratoires Urgo S.A. for the device "ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING". The FDA issued a decision of Substantially Equivalent on Feb 13, 1998. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Laboratoires Urgo S.A. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1998
- Date Received
- Nov 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)