510(k) K960019
K960019 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "RETRACTOR ARM CLAMP". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code FWZ (Operating Room Accessories Table Tray), a Class I device regulated under 21 CFR 878.4950. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1996
- Date Received
- January 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Operating Room Accessories Table Tray
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.