510(k) K943773
K943773 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "STERILE WATER". The FDA issued a decision of Substantially Equivalent on Feb 27, 1995. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 1995
- Date Received
- Aug 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter And Tip, Suction
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type