510(k) K960426
K960426 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on March 21, 1996. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Medical Components, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1996
- Date Received
- January 29, 1996
- 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