The following data is part of a premarket notification filed by Agaplastic Ind. Com. Ltda. with the FDA for Agachamber Spacer.
| Device ID | K101348 |
| 510k Number | K101348 |
| Device Name: | AGACHAMBER SPACER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | AGAPLASTIC IND. COM. LTDA. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin AGAPLASTIC IND. COM. LTDA. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-13 |
| Decision Date | 2011-04-29 |
| Summary: | summary |