The following data is part of a premarket notification filed by Anchor Products Co. with the FDA for Anchor Double-edge Myringotomy Blade.
| Device ID | K884862 |
| 510k Number | K884862 |
| Device Name: | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE |
| Classification | Blade, Scalpel |
| Applicant | ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
| Contact | Robert H Thrun |
| Correspondent | Robert H Thrun ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1988-12-27 |