The following data is part of a premarket notification filed by Heyer Schulte Corp. with the FDA for Mishler 2 Chamb Flushing Valve,anti-syph.
Device ID | K760785 |
510k Number | K760785 |
Device Name: | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH |
Classification | Shunt, Central Nervous System And Components |
Applicant | HEYER SCHULTE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-05 |
Decision Date | 1976-11-01 |