The following data is part of a premarket notification filed by Norpak Mfg., Inc. with the FDA for Antifog.
Device ID | K934347 |
510k Number | K934347 |
Device Name: | ANTIFOG |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | NORPAK MFG., INC. 85 CHAMBERS DRIVE, #8 Ajax, Ontario L1z 1e2, CA |
Contact | Michael Cruickshank |
Correspondent | Michael Cruickshank NORPAK MFG., INC. 85 CHAMBERS DRIVE, #8 Ajax, Ontario L1z 1e2, CA |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-08 |
Decision Date | 1994-01-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ANTIFOG 74490897 not registered Dead/Abandoned |
SAINT-GOBAIN VITRAGE INTERNATIONAL 1994-02-17 |