510(k) K844889
K844889 is an FDA 510(k) premarket notification submitted by Goosen Enterprises, Inc. for the device "MENSINK-GOOSEN CATHETER". The FDA issued a decision of Substantially Equivalent on March 18, 1985. The device falls under product code GBP (Catheter, Multiple Lumen), a Class I device regulated under 21 CFR 878.4200. Goosen Enterprises, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1985
- Date Received
- December 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Multiple Lumen
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type