The following data is part of a premarket notification filed by Medicon Instruments, Inc. with the FDA for Medicon Instruments Trocars, Trocar Sleeves And Reduction Sleeves.
Device ID | K936247 |
510k Number | K936247 |
Device Name: | MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES |
Classification | Trocar |
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 | DRC |
CFR Regulation Number | 870.1390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-30 |
Decision Date | 1994-05-19 |