510(k) K833332
K833332 is an FDA 510(k) premarket notification submitted by Polyclinic Medical Center for the device "SCHULTZ ENDHOLD". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Polyclinic Medical Center has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1983
- Date Received
- September 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type