The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Media Culture System.
Device ID | K040530 |
510k Number | K040530 |
Device Name: | MEDIA CULTURE SYSTEM |
Classification | Media, Reproductive |
Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
Contact | Michael D Cecchi |
Correspondent | Michael D Cecchi INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-01 |
Decision Date | 2004-06-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815965020235 | K040530 | 000 |
00815965020099 | K040530 | 000 |
00815965020105 | K040530 | 000 |
00815965020112 | K040530 | 000 |
00815965020129 | K040530 | 000 |
00815965020136 | K040530 | 000 |
00815965020143 | K040530 | 000 |
00815965020150 | K040530 | 000 |
00815965020167 | K040530 | 000 |
00815965020204 | K040530 | 000 |
00815965020211 | K040530 | 000 |
00815965020228 | K040530 | 000 |
00815965020082 | K040530 | 000 |