The following data is part of a premarket notification filed by Alden Scientific, Inc. with the FDA for Nephretect.
| Device ID | K934066 |
| 510k Number | K934066 |
| Device Name: | NEPHRETECT |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ALDEN SCIENTIFIC, INC. 550 PLEASANT ST. Winthrop, MA 02152 |
| Contact | Adolph E D'amico |
| Correspondent | Adolph E D'amico ALDEN SCIENTIFIC, INC. 550 PLEASANT ST. Winthrop, MA 02152 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1995-05-02 |