510(k) K895752
K895752 is an FDA 510(k) premarket notification submitted by Magnum Diamond, Inc. for the device "DIAMOND BLADE SURGICAL KNIVES". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Magnum Diamond, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1989
- Date Received
- September 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type