The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Barrier Plastic Packaging (modification).
Device ID | K933560 |
510k Number | K933560 |
Device Name: | BARRIER PLASTIC PACKAGING (MODIFICATION) |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | MAXXIM MEDICAL 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Contact | Linda G Hill |
Correspondent | Linda G Hill MAXXIM MEDICAL 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-22 |
Decision Date | 1994-04-11 |