The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Auto Sash (tm).
| Device ID | K904663 |
| 510k Number | K904663 |
| Device Name: | AUTO SASH (TM) |
| Classification | Set, Administration, Intravascular |
| Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Contact | Gregory E Sancoff |
| Correspondent | Gregory E Sancoff BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-12 |
| Decision Date | 1992-11-23 |