The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006).
| Device ID | K964445 |
| 510k Number | K964445 |
| Device Name: | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Contact | Roger W Brick |
| Correspondent | Roger W Brick DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-01-30 |
| Summary: | summary |