The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Pvp (polyvinylpyrrolidone).
Device ID | K022590 |
510k Number | K022590 |
Device Name: | PVP (POLYVINYLPYRROLIDONE) |
Classification | Media, Reproductive |
Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
Contact | Michael D Cecchi |
Correspondent | Michael D Cecchi INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-05 |
Decision Date | 2002-08-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815965021379 | K022590 | 000 |
00815965020747 | K022590 | 000 |