The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Parapac.
| Device ID | K960515 |
| 510k Number | K960515 |
| Device Name: | PARAPAC |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEU PAC, LTD. CRESCENT RD. Luton Beds Lu2 Oah, GB |
| Contact | Norman S Jones, Ph.d. |
| Correspondent | Norman S Jones, Ph.d. PNEU PAC, LTD. CRESCENT RD. Luton Beds Lu2 Oah, GB |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-05 |
| Decision Date | 1996-10-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PARAPAC 77917013 3899002 Live/Registered |
Smiths Medical International Limited 2010-01-21 |
![]() PARAPAC 76001210 2455092 Dead/Cancelled |
INTERVET INC. 2000-03-15 |
![]() PARAPAC 75782595 not registered Dead/Abandoned |
SIMS pneuPAC LIMITED 1999-08-24 |
![]() PARAPAC 74199208 1801376 Dead/Cancelled |
Schering Corporation 1991-08-29 |