The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Searle Vascular Loops.
Device ID | K802485 |
510k Number | K802485 |
Device Name: | SEARLE VASCULAR LOOPS |
Classification | Instrument, Surgical, Disposable |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-10 |
Decision Date | 1981-02-12 |