The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Homepump (disp. Elastomeric Infusion Device).
| Device ID | K896546 |
| 510k Number | K896546 |
| Device Name: | HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) |
| Classification | Pump, Infusion |
| Applicant | BLOCK MEDICAL, INC. 6048-E CORNERSTONE CT. W. San Diego, CA 92121 |
| Contact | Gregory E Sancoff |
| Correspondent | Gregory E Sancoff BLOCK MEDICAL, INC. 6048-E CORNERSTONE CT. W. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-02-06 |