The following data is part of a premarket notification filed by Strato/infusaid, Inc. with the FDA for Strato/infusaid Life & Infuse-a-port Implantable Port System.
| Device ID | K953529 |
| 510k Number | K953529 |
| Device Name: | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Craig M Audet |
| Correspondent | Craig M Audet STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-27 |
| Decision Date | 1996-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787LPS50570 | K953529 | 000 |
| H787LPS72550 | K953529 | 000 |