The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Surgical Instrument Tip.
Device ID | K782144 |
510k Number | K782144 |
Device Name: | DISPOSABLE SURGICAL INSTRUMENT TIP |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | ANAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-27 |
Decision Date | 1979-01-05 |