The following data is part of a premarket notification filed by Medicon Instruments, Inc. with the FDA for Dissectors, Forceps, Scissors, Dilation Sets, And Gall Stone Collectors.
Device ID | K936262 |
510k Number | K936262 |
Device Name: | DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-30 |
Decision Date | 1994-07-01 |