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 Tube, Tympanostomy
510(k) Number K910618
Device Name SUH VENT TUBE
Applicant
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Correspondent Contact STUART K MONTGOMERY
Regulation Number874.3880
Classification Product Code
ETD  
Date Received02/12/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-