The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette.
| Device ID | K990761 |
| 510k Number | K990761 |
| Device Name: | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE |
| Classification | Wrap, Sterilization |
| Applicant | TUTTNAUER USA CO. LTD. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Contact | Mark M Yacura |
| Correspondent | Mark M Yacura TUTTNAUER USA CO. LTD. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-07-09 |
| Summary: | summary |