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 Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K881499
Device Name SURGILASE YAG 100 FOR GYNECOLOGY USE
Applicant
SURGILASE, INC.
I-95 CORPORATE PARK
33 PLAN WAY
WARWICK,  RI  02866
Applicant Contact TIMOTHY J SHEA
Correspondent
SURGILASE, INC.
I-95 CORPORATE PARK
33 PLAN WAY
WARWICK,  RI  02866
Correspondent Contact TIMOTHY J SHEA
Regulation Number874.4500
Classification Product Code
LLO  
Date Received03/22/1988
Decision Date 04/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-