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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K915300
Device Name A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES
Applicant
Alto Development Corp.
5012 Asbury Rd.
P.O. Box 758
Farmingdale,  NJ  07727
Applicant Contact TIM WOJCIECHOWICZ
Correspondent
Alto Development Corp.
5012 Asbury Rd.
P.O. Box 758
Farmingdale,  NJ  07727
Correspondent Contact TIM WOJCIECHOWICZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/21/1991
Decision Date 02/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-