The following data is part of a premarket notification filed by Adler Instrument Co. with the FDA for Maxi-flow Suction Set 12 Ft..
Device ID | K910170 |
510k Number | K910170 |
Device Name: | MAXI-FLOW SUCTION SET 12 FT. |
Classification | Tubing, Noninvasive |
Applicant | ADLER INSTRUMENT CO. 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Contact | Norman Black |
Correspondent | Norman Black ADLER INSTRUMENT CO. 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-15 |
Decision Date | 1991-02-01 |