The following data is part of a premarket notification filed by Medical Marketing Group with the FDA for Aspri-luke.
Device ID | K791847 |
510k Number | K791847 |
Device Name: | ASPRI-LUKE |
Classification | Trap, Sterile Specimen |
Applicant | MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
Contact | Timothy Golden |
Correspondent | Timothy Golden MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
Product Code | BYZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-19 |
Decision Date | 1979-10-02 |