The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Prochek G Glutaraldehyde Concentration Level Indicator.
| Device ID | K960089 |
| 510k Number | K960089 |
| Device Name: | PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | COTTRELL, LTD. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane COTTRELL, LTD. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-04-04 |
| Summary: | summary |