The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Shell Kraton Thermo-plastic Rubber Comp..
| Device ID | K803069 |
| 510k Number | K803069 |
| Device Name: | SHELL KRATON THERMO-PLASTIC RUBBER COMP. |
| Classification | Mouthpiece, Breathing |
| Applicant | WARREN E. COLLINS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-05 |
| Decision Date | 1980-12-22 |