510(k) K853266
K853266 is an FDA 510(k) premarket notification submitted by Westmark Enterprises, Inc. for the device "PLASTIC MOUTH BARRIER HSV-I". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Westmark Enterprises, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1985
- Date Received
- August 5, 1985
- 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