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 Scalpel, One-Piece
510(k) Number K863950
Device Name P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL
Applicant
PRECISION SURGICAL INDUSTRIES, INC.
2507 RTE. 22 W
SCOTCH PLAINS,  NJ  07076
Applicant Contact R. J BEDNER
Correspondent
PRECISION SURGICAL INDUSTRIES, INC.
2507 RTE. 22 W
SCOTCH PLAINS,  NJ  07076
Correspondent Contact R. J BEDNER
Regulation Number878.4800
Classification Product Code
GDX  
Date Received10/10/1986
Decision Date 10/24/1986
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
-
-