510(k) K761297
K761297 is an FDA 510(k) premarket notification submitted by Oem Medical Div. for the device "MOUTHPIECE SEAL". The FDA issued a decision of Substantially Equivalent on January 3, 1977. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Oem Medical Div. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1977
- Date Received
- December 21, 1976
- 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