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 |