The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Double & Single Tantalum Clips.
Device ID | K840207 |
510k Number | K840207 |
Device Name: | DOUBLE & SINGLE TANTALUM CLIPS |
Classification | Clip, Tantalum, Ophthalmic |
Applicant | STORZ INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQW |
CFR Regulation Number | 886.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-19 |
Decision Date | 1984-03-29 |