The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Culture Collection And Transport System, Modified Amies Media.
| Device ID | K964637 |
| 510k Number | K964637 |
| Device Name: | CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | MEDICAL PACKAGING CORP. 941 AVENIDA ACASO Camarillo, CA 93012 -8700 |
| Contact | Patricia V Willis |
| Correspondent | Patricia V Willis MEDICAL PACKAGING CORP. 941 AVENIDA ACASO Camarillo, CA 93012 -8700 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-19 |
| Decision Date | 1996-12-24 |
| Summary: | summary |