The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Clear-therm Micro Hme, Model 1441.
| Device ID | K032322 |
| 510k Number | K032322 |
| Device Name: | CLEAR-THERM MICRO HME, MODEL 1441 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-28 |
| Decision Date | 2004-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267040988 | K032322 | 000 |
| 05030267038312 | K032322 | 000 |