510(k) K872989
K872989 is an FDA 510(k) premarket notification submitted by Micrins Surgical, Inc. for the device "MICRINS NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on August 21, 1987. The device falls under product code HXK (Holder, Needle; Orthopedic), a Class I device regulated under 21 CFR 888.4540. Micrins Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1987
- Date Received
- July 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Needle; Orthopedic
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type