The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Ssw-sterile Solution Warmer.
| Device ID | K002859 |
| 510k Number | K002859 |
| Device Name: | SSW-STERILE SOLUTION WARMER |
| Classification | Warmer, Irrigation Solution |
| Applicant | KMI KOLSTER METHODS, INC. 708 NORTH VALLEY, SUITE N Anaheim, CA 92801 |
| Contact | Alwin H Kolster |
| Correspondent | Alwin H Kolster KMI KOLSTER METHODS, INC. 708 NORTH VALLEY, SUITE N Anaheim, CA 92801 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-11-16 |