510(k) K930330
K930330 is an FDA 510(k) premarket notification submitted by Holmed Corp. for the device "ENDOSCOPIC NEEDLEHOLDER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on Jun 8, 1993. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Holmed Corp. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 1993
- Date Received
- Jan 22, 1993
- 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