The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Filter System, Altner Disposable.
Device ID | K790209 |
510k Number | K790209 |
Device Name: | FILTER SYSTEM, ALTNER DISPOSABLE |
Classification | Tubing, Noninvasive |
Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-30 |
Decision Date | 1979-02-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304731370 | K790209 | 000 |
00880304398498 | K790209 | 000 |
00880304398481 | K790209 | 000 |
00880304398450 | K790209 | 000 |
00880304398443 | K790209 | 000 |