510(k) K873493
K873493 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "NINJA SCALPEL". The FDA issued a decision of Substantially Equivalent on September 24, 1987. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1987
- Date Received
- August 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Scalpel
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type