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 |