• 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 Slide Stainer, Automated
510(k) Number K881592
Device Name WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
Applicant
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Applicant Contact WAYNE K BARLOW
Correspondent
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Correspondent Contact WAYNE K BARLOW
Regulation Number864.3800
Classification Product Code
KPA  
Date Received04/12/1988
Decision Date 05/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-