The following data is part of a premarket notification filed by Medical Products Laboratories, Inc. with the FDA for Varnishamerica.
Device ID | K040098 |
510k Number | K040098 |
Device Name: | VARNISHAMERICA |
Classification | Varnish, Cavity |
Applicant | MEDICAL PRODUCTS LABORATORIES, INC. 9990 GLOBAL RD. Philadelphia, PA 19115 |
Contact | Robert J Malerman |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-01-20 |
Decision Date | 2004-02-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D686200306770 | K040098 | 000 |
10889950141745 | K040098 | 000 |
50732224005558 | K040098 | 000 |
50732224005565 | K040098 | 000 |
50732224005572 | K040098 | 000 |
D686200327620 | K040098 | 000 |
D686200327630 | K040098 | 000 |
D686200327640 | K040098 | 000 |
D686200327650 | K040098 | 000 |
D686200327700 | K040098 | 000 |
D686200306730 | K040098 | 000 |
D686200306740 | K040098 | 000 |
D686200306750 | K040098 | 000 |
D686200306760 | K040098 | 000 |
10889950141738 | K040098 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VARNISHAMERICA 86045104 4536542 Live/Registered |
Medical Products Laboratories, Inc. 2013-08-22 |