The following data is part of a premarket notification filed by Rohm And Haas Co. with the FDA for Equipment/material Decontaminating Kit.
| Device ID | K911299 |
| 510k Number | K911299 |
| Device Name: | EQUIPMENT/MATERIAL DECONTAMINATING KIT |
| Classification | Apparatus, High Pressure Liquid Chromatography |
| Applicant | ROHM AND HAAS CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Peter O Safir |
| Correspondent | Peter O Safir ROHM AND HAAS CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | KIE |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-04-08 |