The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Pilling Weck Surgical Y Stent Forceps.
Device ID | K990547 |
510k Number | K990547 |
Device Name: | PILLING WECK SURGICAL Y STENT FORCEPS |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
Contact | Julie A Beaumont |
Correspondent | Julie A Beaumont PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
Product Code | EOQ |
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 | 1999-04-27 |
Summary: | summary |