The following data is part of a premarket notification filed by Technology Transfer Intl., Inc. with the FDA for Micrel Ltd - Portable Infusion Micropump-mp11.
Device ID | K910758 |
510k Number | K910758 |
Device Name: | MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11 |
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 | 1991-01-28 |
Decision Date | 1991-05-30 |