GLUTATECT
Indicator, Physical/chemical Sterilization Process
ALDEN SCIENTIFIC, INC.
The following data is part of a premarket notification filed by Alden Scientific, Inc. with the FDA for Glutatect.
Pre-market Notification Details
| Device ID | K971888 |
| 510k Number | K971888 |
| Device Name: | GLUTATECT |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ALDEN SCIENTIFIC, INC. 360 COLD SPRING AVE. Springfield, MA 01089 |
| Contact | Adolph E D'amico |
| Correspondent | Adolph E D'amico ALDEN SCIENTIFIC, INC. 360 COLD SPRING AVE. Springfield, MA 01089 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-21 |
| Decision Date | 1998-01-09 |
Trademark Results [GLUTATECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLUTATECT 75479622 2366897 Dead/Cancelled |
METREX RESEARCH CORPORATION 1998-05-05 |
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