510(k) K864970
K864970 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "TERUMO DENTAL NEEDLES". The FDA issued a decision of Substantially Equivalent on March 10, 1987. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1987
- Date Received
- December 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Dental
- Device Class
- Class I
- Regulation Number
- 872.4730
- Review Panel
- DE
- Submission Type