510(k) K854812
K854812 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "NELSON-JUNG PLEURAL CATH". The FDA issued a decision of Substantially Equivalent on February 11, 1986. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Research Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1986
- Date Received
- December 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peritoneal
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type