The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Trocar System According To Hasson.
| Device ID | K990237 |
| 510k Number | K990237 |
| Device Name: | TROCAR SYSTEM ACCORDING TO HASSON |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-24 |
| Decision Date | 1999-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761009109 | K990237 | 000 |
| 14042761009048 | K990237 | 000 |
| 14042761009031 | K990237 | 000 |
| 14042761006214 | K990237 | 000 |
| 14042761006207 | K990237 | 000 |
| 04042761009188 | K990237 | 000 |
| 04042761009072 | K990237 | 000 |
| 04042761008952 | K990237 | 000 |
| 04042761030762 | K990237 | 000 |