The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Intersurgical Inter-therm Breathing Filter And Heat And Moisture Exchanger, Intersurgical Inter-guard Breathing Filter.
| Device ID | K092451 |
| 510k Number | K092451 |
| Device Name: | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER |
| 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 | 2009-08-10 |
| Decision Date | 2010-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267083824 | K092451 | 000 |
| 05030267083800 | K092451 | 000 |
| 05030267083787 | K092451 | 000 |
| 05030267083725 | K092451 | 000 |
| 05030267083701 | K092451 | 000 |
| 05030267083688 | K092451 | 000 |
| 05030267091232 | K092451 | 000 |
| 05030267047932 | K092451 | 000 |