The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. with the FDA for Trocars.
Device ID | K922685 |
510k Number | K922685 |
Device Name: | TROCARS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ENDOSCOPIC TECHNOLOGIES, INC. 2225 SKYLAND COURT Norcross, GA 30071 |
Contact | Freddie P Andrieni |
Correspondent | Freddie P Andrieni ENDOSCOPIC TECHNOLOGIES, INC. 2225 SKYLAND COURT Norcross, GA 30071 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-04 |
Decision Date | 1993-04-05 |