The following data is part of a premarket notification filed by Mayaguez Medical Center with the FDA for Endoscopic Cable/wire Cover.
Device ID | K931707 |
510k Number | K931707 |
Device Name: | ENDOSCOPIC CABLE/WIRE COVER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club, TX 76262 |
Contact | John Mayall |
Correspondent | John Mayall MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club, TX 76262 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-06 |
Decision Date | 1993-08-06 |