The following data is part of a premarket notification filed by Whiteline Plastics, Inc. with the FDA for Face-2-face Cpr Protection Shield.
| Device ID | K991617 |
| 510k Number | K991617 |
| Device Name: | FACE-2-FACE CPR PROTECTION SHIELD |
| Classification | Valve, Non-rebreathing |
| Applicant | WHITELINE PLASTICS, INC. 6800 COLUMBUS ROAD Mississauga, Ontario, CA L5t 2g1 |
| Contact | Wally Simpson |
| Correspondent | Wally Simpson WHITELINE PLASTICS, INC. 6800 COLUMBUS ROAD Mississauga, Ontario, CA L5t 2g1 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-11-03 |