The following data is part of a premarket notification filed by Healthtek Microsurgical, Inc. with the FDA for Scopescrubber(tm).
| Device ID | K902683 |
| 510k Number | K902683 |
| Device Name: | SCOPESCRUBBER(TM) |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | HEALTHTEK MICROSURGICAL, INC. JEFF MANNI, SUITE 400 6 NEW ENGLAND EXECUTIVE PARK Burlington, MA 01803 |
| Contact | Jm Associates |
| Correspondent | Jm Associates HEALTHTEK MICROSURGICAL, INC. JEFF MANNI, SUITE 400 6 NEW ENGLAND EXECUTIVE PARK Burlington, MA 01803 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994662129 | K902683 | 000 |
| 20613994661931 | K902683 | 000 |
| 20613994146353 | K902683 | 000 |
| 20613994146346 | K902683 | 000 |
| 20613994146339 | K902683 | 000 |
| 20643169437191 | K902683 | 000 |
| 20643169437184 | K902683 | 000 |
| 20643169437177 | K902683 | 000 |
| 20643169437160 | K902683 | 000 |
| 00643169433779 | K902683 | 000 |
| 00681490046039 | K902683 | 000 |
| 20613994661948 | K902683 | 000 |
| 20613994661955 | K902683 | 000 |
| 20613994661962 | K902683 | 000 |
| 20613994662105 | K902683 | 000 |
| 20613994662082 | K902683 | 000 |
| 20613994662075 | K902683 | 000 |
| 20613994662051 | K902683 | 000 |
| 20613994662044 | K902683 | 000 |
| 20613994662037 | K902683 | 000 |
| 20613994662020 | K902683 | 000 |
| 20613994662013 | K902683 | 000 |
| 20613994662006 | K902683 | 000 |
| 20613994661993 | K902683 | 000 |
| 00763000008147 | K902683 | 000 |