The following data is part of a premarket notification filed by Pro-tech Services, Inc. with the FDA for Pro-flow Multipurpose Cannula.
| Device ID | K053063 |
| 510k Number | K053063 |
| Device Name: | PRO-FLOW MULTIPURPOSE CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. Mukilteo, WA 98275 |
| Contact | Neil Sheller |
| Correspondent | Neil Sheller PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. Mukilteo, WA 98275 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2005-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959040205 | K053063 | 000 |
| 30606959032348 | K053063 | 000 |
| 30606959032331 | K053063 | 000 |
| 40606959032321 | K053063 | 000 |
| 30606959032317 | K053063 | 000 |
| 30606959032300 | K053063 | 000 |