The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Proview Self-sealing Sterilization Pouch.
Device ID | K893802 |
510k Number | K893802 |
Device Name: | PROVIEW SELF-SEALING STERILIZATION POUCH |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
Contact | Mark Frampton |
Correspondent | Mark Frampton COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-22 |
Decision Date | 1990-04-04 |