The following data is part of a premarket notification filed by Hdc Medical, Inc. with the FDA for Peracidin Dialyzer Reprocessing Concentrate.
| Device ID | K962959 |
| 510k Number | K962959 |
| Device Name: | PERACIDIN DIALYZER REPROCESSING CONCENTRATE |
| Classification | Sterilant, Medical Devices |
| Applicant | HDC MEDICAL, INC. 9223 ILONA LN. Houston, TX 77025 -4218 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones HDC MEDICAL, INC. 9223 ILONA LN. Houston, TX 77025 -4218 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1998-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858293006332 | K962959 | 000 |
| 00898021000204 | K962959 | 000 |
| 00898021000228 | K962959 | 000 |
| 00898021000181 | K962959 | 000 |
| 00858293006922 | K962959 | 000 |
| 00898021000419 | K962959 | 000 |
| 20898021000406 | K962959 | 000 |
| 20898021000383 | K962959 | 000 |