510(k) K874370
K874370 is an FDA 510(k) premarket notification submitted by Derma-Safe Co. for the device "SURGICAL PREP RAZOR". The FDA issued a decision of Substantially Equivalent on November 13, 1987. The device falls under product code LWK (Razor, Surgical), a Class I device regulated under 21 CFR 878.4800. Derma-Safe Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1987
- Date Received
- October 26, 1987
- 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