510(k) K910524
K910524 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SURGICAL CLIPPER". The FDA issued a decision of Substantially Equivalent on March 28, 1991. The device falls under product code LWK (Razor, Surgical), a Class I device regulated under 21 CFR 878.4800. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1991
- Date Received
- February 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Razor, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type