The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Locking Pivotal Thoracoport.
Device ID | K930463 |
510k Number | K930463 |
Device Name: | LOCKING PIVOTAL THORACOPORT |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
Contact | Laszlo Fazekas |
Correspondent | Laszlo Fazekas SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-28 |
Decision Date | 1993-09-07 |