510(k) K851780
K851780 is an FDA 510(k) premarket notification submitted by Artiberia for the device "25-230 TO 25-390 VARIOUS NEEDLE HOLDERS". The FDA issued a decision of Substantially Equivalent on Jun 20, 1985. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 1985
- Date Received
- Apr 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Holder, Needle, Gastroenterologic
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type
- 510(k) Exempt