The following data is part of a premarket notification filed by Narco Scientific with the FDA for Pilling Identi-loops.
Device ID | K820377 |
510k Number | K820377 |
Device Name: | PILLING IDENTI-LOOPS |
Classification | Retractor |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-09 |
Decision Date | 1982-03-10 |