The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Cannula, Perfusion, Fallopian Tube.
Device ID | K772230 |
510k Number | K772230 |
Device Name: | CANNULA, PERFUSION, FALLOPIAN TUBE |
Classification | Cannula, Manipulator/injector, Uterine |
Applicant | J. SKLAR MFG. CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LKF |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-06 |
Decision Date | 1978-01-03 |