510(k) K760985
K760985 is an FDA 510(k) premarket notification submitted by Adp Intl., Inc. for the device "HAND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on November 15, 1976. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Adp Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1976
- Date Received
- October 21, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Broach, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type