510(k) K861757
K861757 is an FDA 510(k) premarket notification submitted by Jackson Plastics, Inc. for the device "5 IN 1 CONNECTOR". The FDA issued a decision of Substantially Equivalent on June 6, 1986. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1986
- Date Received
- May 6, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type