The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Robbett Microsurgical Laryngoscope.
| Device ID | K770085 |
| 510k Number | K770085 |
| Device Name: | ROBBETT MICROSURGICAL LARYNGOSCOPE |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQN |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-14 |
| Decision Date | 1977-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704532032 | K770085 | 000 |
| 04026704417322 | K770085 | 000 |
| 04026704531431 | K770085 | 000 |
| 04026704417339 | K770085 | 000 |
| 04026704531462 | K770085 | 000 |
| 04026704417346 | K770085 | 000 |
| 04026704531486 | K770085 | 000 |
| 04026704417353 | K770085 | 000 |
| 04026704531820 | K770085 | 000 |
| 04026704417414 | K770085 | 000 |
| 04026704417438 | K770085 | 000 |
| 04026704532018 | K770085 | 000 |
| 04026704417445 | K770085 | 000 |
| 24026704531824 | K770085 | 000 |