510(k) K812389
K812389 is an FDA 510(k) premarket notification submitted by Berkeley Medevices for the device "SURGICAL LOOPS". The FDA issued a decision of Substantially Equivalent on Nov 16, 1981. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Berkeley Medevices has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 1981
- Date Received
- Aug 20, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt