The following data is part of a premarket notification filed by Dpt Laboratories, Ltd. with the FDA for Allclenz Wound Cleanser.
| Device ID | K965120 |
| 510k Number | K965120 |
| Device Name: | ALLCLENZ WOUND CLEANSER |
| Classification | Bandage, Liquid |
| Applicant | DPT LABORATORIES, LTD. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer DPT LABORATORIES, LTD. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-21 |
| Summary: | summary |