510(k) K955657
K955657 is an FDA 510(k) premarket notification submitted by North State Plastics, Inc. for the device "NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. North State Plastics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1996
- Date Received
- December 12, 1995
- 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