The following data is part of a premarket notification filed by Pilling Weck Surgical with the FDA for Optical Forceps.
| Device ID | K990561 |
| 510k Number | K990561 |
| Device Name: | OPTICAL FORCEPS |
| Classification | Forceps, Biopsy, Bronchoscope (rigid) |
| Applicant | PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | JEK |
| Subsequent Product Code | EOX |
| Subsequent Product Code | EWY |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-05-14 |
| Summary: | summary |