510(k) K771859
K771859 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "NEEDLE HOLDER, MICROVASCULAR". The FDA issued a decision of Substantially Equivalent on Oct 4, 1977. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Edward Weck, Inc. has 139 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 1977
- Date Received
- Sep 29, 1977
- 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