The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Audible Trocar Ii.
| Device ID | K992250 |
| 510k Number | K992250 |
| Device Name: | CORE AUDIBLE TROCAR II |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CORE DYNAMICS, INC. 11222 ST. JOHNS IND. PKWY. NORTH Jacksonville, FL 32246 -6675 |
| Contact | Thomas M Mcintosh |
| Correspondent | Thomas M Mcintosh CORE DYNAMICS, INC. 11222 ST. JOHNS IND. PKWY. NORTH Jacksonville, FL 32246 -6675 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405055402 | K992250 | 000 |
| 10653405047896 | K992250 | 000 |
| 10653405045960 | K992250 | 000 |
| 10653405045977 | K992250 | 000 |
| 10653405046004 | K992250 | 000 |
| 10653405046011 | K992250 | 000 |
| 10653405046059 | K992250 | 000 |
| 10653405046066 | K992250 | 000 |
| 10653405046073 | K992250 | 000 |
| 10653405046080 | K992250 | 000 |
| 10653405046097 | K992250 | 000 |
| 10653405046103 | K992250 | 000 |
| 10653405046110 | K992250 | 000 |
| 10653405046127 | K992250 | 000 |
| 10653405046134 | K992250 | 000 |
| 10653405046141 | K992250 | 000 |
| 10653405046158 | K992250 | 000 |
| 10653405047902 | K992250 | 000 |
| 10653405045984 | K992250 | 000 |