The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Mcintosh, Miller, Foregger Baby.
Device ID | K945425 |
510k Number | K945425 |
Device Name: | MCINTOSH, MILLER, FOREGGER BABY |
Classification | Laryngoscope, Rigid |
Applicant | RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
Contact | Karlheinz Riester |
Correspondent | Karlheinz Riester RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-04 |
Decision Date | 1995-03-20 |