The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Counter, Disposable Surgical Needle.
Device ID | K790039 |
510k Number | K790039 |
Device Name: | COUNTER, DISPOSABLE SURGICAL NEEDLE |
Classification | Container, Sharps |
Applicant | ANAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-08 |
Decision Date | 1979-01-17 |