510(k) K933109
K933109 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 28, 1994. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- March 28, 1994
- Date Received
- June 25, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type