510(k) K974327
K974327 is an FDA 510(k) premarket notification submitted by Phx Technologies Corp. for the device "WINGED NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on Jan 9, 1998. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Phx Technologies Corp. has 48 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 9, 1998
- Date Received
- Nov 18, 1997
- 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