Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K914690
Device Name LM15(TM), CATALOG NUMBER - 523821
Applicant
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Applicant Contact GLENN MATTEI
Correspondent
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Correspondent Contact GLENN MATTEI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/18/1991
Decision Date 03/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-