510(k) K893791
K893791 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "BREATHING MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Diemolding Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1989
- Date Received
- May 22, 1989
- 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