The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Hepa Filtered Hme.
| Device ID | K930816 |
| 510k Number | K930816 |
| Device Name: | HEPA FILTERED HME |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1993-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315083369 | K930816 | 000 |