The following data is part of a premarket notification filed by Weck Endoscopy with the FDA for Endoscope And Accessories.
Device ID | K926223 |
510k Number | K926223 |
Device Name: | ENDOSCOPE AND ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | WECK ENDOSCOPY P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
Contact | Joseph Mertis |
Correspondent | Joseph Mertis WECK ENDOSCOPY P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-10 |
Decision Date | 1993-04-20 |