VIRTUOSAPH
Laparoscope, General & Plastic Surgery
TERUMO CARDIOVASCULAR SYSTEMS CORP.
The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Virtuosaph.
Pre-market Notification Details
| Device ID | K031891 |
| 510k Number | K031891 |
| Device Name: | VIRTUOSAPH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Kim Aves |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-07-29 |
| Summary: | summary |
Trademark Results [VIRTUOSAPH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIRTUOSAPH 76551721 2977735 Live/Registered |
Terumo Kabushiki Kaisha 2003-09-25 |
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