The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis+geck Absorbable Ligating Device.
Device ID | K925602 |
510k Number | K925602 |
Device Name: | DAVIS+GECK ABSORBABLE LIGATING DEVICE |
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 | 1992-11-05 |
Decision Date | 1993-07-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521057651 | K925602 | 000 |
10884521057630 | K925602 | 000 |
20884521057668 | K925602 | 000 |
20884521057675 | K925602 | 000 |
20884521057699 | K925602 | 000 |
10884521208438 | K925602 | 000 |
10884521057586 | K925602 | 000 |
20884521208466 | K925602 | 000 |
10884521201941 | K925602 | 000 |
20884521057644 | K925602 | 000 |
10884521057623 | K925602 | 000 |