The following data is part of a premarket notification filed by Paul Ritzau Pari-werk Gmbh with the FDA for Pari Filter/valve Set.
Device ID | K926455 |
510k Number | K926455 |
Device Name: | PARI FILTER/VALVE SET |
Classification | Nebulizer (direct Patient Interface) |
Applicant | PAUL RITZAU PARI-WERK GMBH C/O MCGUIRE WOODS BATTLE/BOOTH 901 EAST CARY STREET Richmond, VA 23219 |
Contact | Deborah M Russell |
Correspondent | Deborah M Russell PAUL RITZAU PARI-WERK GMBH C/O MCGUIRE WOODS BATTLE/BOOTH 901 EAST CARY STREET Richmond, VA 23219 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-24 |
Decision Date | 1993-09-28 |