510(k) K871999

MMG URO-SELF CATHETER by Medical Marketing Group — Product Code GBM

K871999 is an FDA 510(k) premarket notification submitted by Medical Marketing Group for the device "MMG URO-SELF CATHETER". The FDA issued a decision of Substantially Equivalent on August 25, 1987. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Medical Marketing Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1987
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type