The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Culture-pak Collection And Transport System With Clinical Transport Media (cary-blair Option).
| Device ID | K970597 |
| 510k Number | K970597 |
| Device Name: | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) |
| 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 | 1997-02-18 |
| Decision Date | 1997-03-24 |
| Summary: | summary |