The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis+geck Reusable Trtocars.
Device ID | K930254 |
510k Number | K930254 |
Device Name: | DAVIS+GECK REUSABLE TRTOCARS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Contact | Tamsett |
Correspondent | Tamsett DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1994-03-24 |