The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Cannual And Trocar, Superpubic.
| Device ID | K950457 |
| 510k Number | K950457 |
| Device Name: | CANNUAL AND TROCAR, SUPERPUBIC |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Contact | Bill Dennis |
| Correspondent | Bill Dennis CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1995-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405044899 | K950457 | 000 |
| 10653405045267 | K950457 | 000 |
| 10653405045274 | K950457 | 000 |
| 10653405045281 | K950457 | 000 |
| 10653405045298 | K950457 | 000 |
| 10653405045304 | K950457 | 000 |
| 10653405045311 | K950457 | 000 |
| 10653405045335 | K950457 | 000 |
| 10653405045342 | K950457 | 000 |
| 10653405045250 | K950457 | 000 |
| 10653405045205 | K950457 | 000 |
| 30653405044905 | K950457 | 000 |
| 10653405045120 | K950457 | 000 |
| 10653405045137 | K950457 | 000 |
| 10653405045144 | K950457 | 000 |
| 10653405045168 | K950457 | 000 |
| 10653405045175 | K950457 | 000 |
| 10653405045182 | K950457 | 000 |
| 10653405045199 | K950457 | 000 |
| 10653405045359 | K950457 | 000 |
| 10653405045380 | K950457 | 000 |
| 10653405045687 | K950457 | 000 |
| 10653405046783 | K950457 | 000 |
| 10653405047698 | K950457 | 000 |
| 10653405047728 | K950457 | 000 |
| 10653405047926 | K950457 | 000 |
| 30653405050197 | K950457 | 000 |
| 30653405050203 | K950457 | 000 |
| 10653405055396 | K950457 | 000 |
| 20653405050176 | K950457 | 000 |
| 10653405046165 | K950457 | 000 |
| 10653405045946 | K950457 | 000 |
| 10653405045694 | K950457 | 000 |
| 10653405045755 | K950457 | 000 |
| 10653405045779 | K950457 | 000 |
| 10653405045885 | K950457 | 000 |
| 10653405045892 | K950457 | 000 |
| 10653405045908 | K950457 | 000 |
| 10653405045922 | K950457 | 000 |
| 10653405045939 | K950457 | 000 |
| 20653405050183 | K950457 | 000 |