The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Culture Collection Device.
Device ID | K881105 |
510k Number | K881105 |
Device Name: | CULTURE COLLECTION DEVICE |
Classification | Culture Media, Non-propagating Transport |
Applicant | MEDICAL PACKAGING CORP. 941 AVENIDA ACASO Camarillo, CA 93012 -8700 |
Contact | Frederic L Nason |
Correspondent | Frederic L Nason 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 | 1988-03-15 |
Decision Date | 1988-04-25 |