The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Fraser Harlake Nitronox Scavenger.
| Device ID | K821744 |
| 510k Number | K821744 |
| Device Name: | FRASER HARLAKE NITRONOX SCAVENGER |
| Classification | Apparatus, Gas-scavenging |
| Applicant | FRASER HARLAKE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-14 |
| Decision Date | 1982-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816711020547 | K821744 | 000 |
| 00816711020530 | K821744 | 000 |
| 00816711020479 | K821744 | 000 |
| 00816711020462 | K821744 | 000 |
| 00816711020455 | K821744 | 000 |
| 00816711020448 | K821744 | 000 |
| 00816711020431 | K821744 | 000 |
| 00816711023951 | K821744 | 000 |