The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Models Sp5825/sp5835/sp5845/sp5855 Percu. Sheath.
| Device ID | K881825 |
| 510k Number | K881825 |
| Device Name: | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH |
| Classification | Introducer, Catheter |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-29 |
| Decision Date | 1988-09-28 |