The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Spacemaker System.
| Device ID | K042412 |
| 510k Number | K042412 |
| Device Name: | MODIFIED SPACEMAKER SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Renee Alfano |
| Correspondent | Renee Alfano UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2004-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521067417 | K042412 | 000 |
| 20884521067834 | K042412 | 000 |
| 20884521067827 | K042412 | 000 |
| 20884521067575 | K042412 | 000 |