The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Obturator, Deflecting.
Device ID | K760183 |
510k Number | K760183 |
Device Name: | OBTURATOR, DEFLECTING |
Classification | Obturator, For Endoscope |
Applicant | V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-12-02 |