The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Drape, Transurethral Resection (tur).
Device ID | K760175 |
510k Number | K760175 |
Device Name: | DRAPE, TRANSURETHRAL RESECTION (TUR) |
Classification | Drape, Pure Latex Sheet, With Self-retaining Finger Cot |
Applicant | V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EYX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-08-30 |