Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K191741 |
Device Name |
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape |
Applicant |
Intertape Polymer Inc. |
100 Paramount Dr Suite 300 |
Sarasota,
FL
34232
|
|
Applicant Contact |
Michael Bryant |
Correspondent |
Highpower Validation Testing & Lab Service's Inc. |
125 Highpower Road |
Rochester,
NY
14623
|
|
Correspondent Contact |
Gary J. Socola |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 07/01/2019 |
Decision Date | 08/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|