The following data is part of a premarket notification filed by Isratech Marketing Corp. with the FDA for Tissue Culture/bacteriological Petri Dishes.
Device ID | K871483 |
510k Number | K871483 |
Device Name: | TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES |
Classification | Dish, Tissue Culture |
Applicant | ISRATECH MARKETING CORP. 200 MADISON AVE. New York, NY 10016 |
Contact | Efraim Margolin |
Correspondent | Efraim Margolin ISRATECH MARKETING CORP. 200 MADISON AVE. New York, NY 10016 |
Product Code | KIZ |
CFR Regulation Number | 864.2240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-15 |
Decision Date | 1987-04-29 |