The following data is part of a premarket notification filed by Adler Instrument Co. with the FDA for Maxi-flow Insufflator Tubing Set W/filter.
| Device ID | K903209 |
| 510k Number | K903209 |
| Device Name: | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| 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 | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-20 |
| Decision Date | 1990-12-21 |