The following data is part of a premarket notification filed by Snyder Laboratories, Inc. with the FDA for Snyder Hysterectomy Y Tube Kit.
Device ID | K800543 |
510k Number | K800543 |
Device Name: | SNYDER HYSTERECTOMY Y TUBE KIT |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | SNYDER LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-10 |
Decision Date | 1980-04-16 |