510(k) K821354
K821354 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR MAYO HEGAR NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on Jun 3, 1982. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 3, 1982
- Date Received
- May 5, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Guide, Needle, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt