Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

510(k) Premarket Notification

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 


New Search Back To Search Results
Device Classification Name laparoscope, gynecologic (and accessories)
510(k) NumberK953574
Device NameNEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
Applicant
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.
430 commerce dr.
delray beach,  FL  33445
Contactmartine d schneider
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/31/1995
Decision Date 09/29/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Statement/Summary/Purged Status Summary only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
-
-
-
-
-