The following data is part of a premarket notification filed by North State Plastics, Inc. with the FDA for North State Plastics Respiratory Mouthpiece.
| Device ID | K955657 |
| 510k Number | K955657 |
| Device Name: | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE |
| Classification | Mouthpiece, Breathing |
| Applicant | NORTH STATE PLASTICS, INC. 12850 EAST 40TH AVE., SUITE 98 Denver, CO 80239 |
| Contact | Alex Mckinnon |
| Correspondent | Alex Mckinnon NORTH STATE PLASTICS, INC. 12850 EAST 40TH AVE., SUITE 98 Denver, CO 80239 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-03-12 |
| Summary: | summary |