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 |