510(k) K813448
K813448 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "POTTS-COURNAND STYLE NEEDLE". The FDA issued a decision of Substantially Equivalent on January 7, 1982. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1982
- Date Received
- December 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type