The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Culture-pak Collection And Transport System.
Device ID | K932337 |
510k Number | K932337 |
Device Name: | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM |
Classification | Culture Media, Non-propagating Transport |
Applicant | MEDICAL PACKAGING CORP. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
Contact | Joyce T Davis |
Correspondent | Joyce T Davis MEDICAL PACKAGING CORP. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-14 |
Decision Date | 1994-08-16 |