The following data is part of a premarket notification filed by Temed with the FDA for Temed Gas Diffuser.
| Device ID | K173545 |
| 510k Number | K173545 |
| Device Name: | TEMED Gas Diffuser |
| Classification | Insufflator, Laparoscopic |
| Applicant | TEMED Unit 3, Keynor Farm Sidlesham, GB Po20 7ll |
| Contact | Katie Evans |
| Correspondent | Katie Evans TEMED Unit 3, Keynor Farm Sidlesham, GB Po20 7ll |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-16 |
| Decision Date | 2018-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060660970025 | K173545 | 000 |