ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12


Device Classification Name

media, reproductive

510(k) Number K023222
Device Name ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
Original Applicant
INVITROCARE, INC.
8415 progress drive
suite f
frederick, 
MD 
21701

Original Contact robert e lovins
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 09/27/2002
Decision Date 12/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No