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 Speculum, Vaginal, Nonmetal
510(k) Number K091937
Device Name OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
Applicant
Obp Corporation
360 Merrimack St.,
Bldg.#9
Lawerence,  MA  01843
Applicant Contact KEITH ISAACSON
Correspondent
Obp Corporation
360 Merrimack St.,
Bldg.#9
Lawerence,  MA  01843
Correspondent Contact KEITH ISAACSON
Regulation Number884.4530
Classification Product Code
HIB  
Date Received06/30/2009
Decision Date 09/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-