The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Glutaraldehyde Monitors.
| Device ID | K924681 |
| 510k Number | K924681 |
| Device Name: | GLUTARALDEHYDE MONITORS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Contact | Thomas Thackston |
| Correspondent | Thomas Thackston PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-16 |
| Decision Date | 1993-11-17 |