The following data is part of a premarket notification filed by Technology Transfer Intl., Inc. with the FDA for Micrel Ltd Portable Infusion Micropump.
Device ID | K903571 |
510k Number | K903571 |
Device Name: | MICREL LTD PORTABLE INFUSION MICROPUMP |
Classification | Pump, Infusion |
Applicant | TECHNOLOGY TRANSFER INTL., INC. 8130 BOONE BLVD. SUITE 240 Vienna, VA 22182 |
Contact | Caesar A Roy |
Correspondent | Caesar A Roy TECHNOLOGY TRANSFER INTL., INC. 8130 BOONE BLVD. SUITE 240 Vienna, VA 22182 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1991-02-01 |