510(k) K832686
K832686 is an FDA 510(k) premarket notification submitted by Hirata Sangyo Co. USA, Inc. for the device "MULTIPLE MANUAL SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Hirata Sangyo Co. USA, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1983
- Date Received
- August 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reamer
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type