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 |