510(k) K865093
K865093 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "SAFE-T-SHIELD MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on January 15, 1987. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Medi Nuclear Corp., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 1987
- Date Received
- December 30, 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