The following data is part of a premarket notification filed by Medical Technical Products with the FDA for Part #860065 Ia Pak & Part #860060 Ia Pak.
Device ID | K871473 |
510k Number | K871473 |
Device Name: | PART #860065 IA PAK & PART #860060 IA PAK |
Classification | Unit, Phacofragmentation |
Applicant | MEDICAL TECHNICAL PRODUCTS 14 HUGHES STREET, SUITE B104 Irvine, CA 92718 |
Contact | Thomas V Keeley |
Correspondent | Thomas V Keeley MEDICAL TECHNICAL PRODUCTS 14 HUGHES STREET, SUITE B104 Irvine, CA 92718 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-14 |
Decision Date | 1987-08-10 |