The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Sterile Polyhesive Pbs Dressing.
| Device ID | K890021 |
| 510k Number | K890021 |
| Device Name: | STERILE POLYHESIVE PBS DRESSING |
| Classification | Adhesive, Tissue For Aneurysmorrhaphy |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | KGF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-04 |
| Decision Date | 1989-06-01 |