510(k) K905812
K905812 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "INTRAUTERINE CATHETER SET". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code HGS (Catheter, Intrauterine And Introducer), a Class II device regulated under 21 CFR 884.2700. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1991
- Date Received
- December 28, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intrauterine And Introducer
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type