510(k) K862788
K862788 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "MP-4400 MOUTHPIECE-FLANGE SEAL". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1986
- Date Received
- July 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthpiece, Breathing
- Device Class
- Class I
- Regulation Number
- 868.5620
- Review Panel
- AN
- Submission Type