The following data is part of a premarket notification filed by Fsc Laboratories, Inc. with the FDA for Fsc Anti-static Valved Collapsible Holding Chamber.
| Device ID | K140062 |
| 510k Number | K140062 |
| Device Name: | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | FSC LABORATORIES, INC. 6000 Fairview Rd. Suite 600 Charlotte, NC 28210 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden FSC LABORATORIES, INC. 6000 Fairview Rd. Suite 600 Charlotte, NC 28210 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00323594901011 | K140062 | 000 |
| 00032359490201 | K140062 | 000 |