The following data is part of a premarket notification filed by Stat Path with the FDA for Histogrip & Histogrip Gold Concentrate/prediluted.
| Device ID | K881477 |
| 510k Number | K881477 |
| Device Name: | HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED |
| Classification | Adhesive, Albumin-based |
| Applicant | STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
| Contact | R Bostwick |
| Correspondent | R Bostwick STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
| Product Code | KEL |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-07 |
| Decision Date | 1988-04-18 |