The following data is part of a premarket notification filed by Plasmapp Co,.ltd with the FDA for Sterlinktm Fps-15s Plus Sterilizer With Sterloadtm Cassette.
| Device ID | K212200 |
| 510k Number | K212200 |
| Device Name: | STERLINKTM FPS-15s Plus Sterilizer With STERLOADTM Cassette |
| Classification | Sterilizer, Chemical |
| Applicant | Plasmapp Co,.Ltd BVC-111, 125, Gwahak-ro, Yuseong-gu Daejeon, KR 34141 |
| Contact | Lee Seung Hun |
| Correspondent | Candace Cederman CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, MD 21401 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800066500054 | K212200 | 000 |
| 08800066500030 | K212200 | 000 |
| 08800066500313 | K212200 | 000 |