Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K211490
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K211490
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
Stryker Corporation
4100 East Milham Avenue
Kalamazoo, MI 49001 US
Other 510(k) Applications for this Company
Contact
John Chesney
Other 510(k) Applications for this Contact
Regulation Number
874.4250
More FDA Info for this Regulation Number
Classification Product Code
ERL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2021
Decision Date
06/09/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact