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 Dressing, Wound, Occlusive
510(k) Number K952203
Device Name OTOSILK
Applicant
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact STUART K MONTGOMERY
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/10/1995
Decision Date 07/31/1995
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
-
-