The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Endoscopic Anti Fog Device.
| Device ID | K993604 |
| 510k Number | K993604 |
| Device Name: | ENDOSCOPIC ANTI FOG DEVICE |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Contact | Charles E Allgood |
| Correspondent | Charles E Allgood MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-25 |
| Decision Date | 2000-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817984011236 | K993604 | 000 |
| 10817984010133 | K993604 | 000 |
| 20817984010185 | K993604 | 000 |
| 10817984010195 | K993604 | 000 |
| 10817984010201 | K993604 | 000 |
| 10817984010898 | K993604 | 000 |
| 10817984010935 | K993604 | 000 |
| 20817984010949 | K993604 | 000 |
| 10817984011123 | K993604 | 000 |
| 10817984011130 | K993604 | 000 |
| 10817984011208 | K993604 | 000 |
| 10817984011215 | K993604 | 000 |
| 10849771037856 | K993604 | 000 |