The following data is part of a premarket notification filed by Ranfac Corp with the FDA for Ranfac Fat Aspiration Transfer Syringe (fats) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (fats) Containment Vessel.
Device ID | K150156 |
510k Number | K150156 |
Device Name: | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel |
Classification | System, Suction, Lipoplasty |
Applicant | Ranfac Corp 30 Doherty Ave Avon, MA 02322 |
Contact | Christopher P Whelan |
Correspondent | Christopher P Whelan Ranfac Corp 30 Doherty Ave Avon, MA 02322 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-23 |
Decision Date | 2015-10-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850023741575 | K150156 | 000 |
00858690006808 | K150156 | 000 |
10858690006836 | K150156 | 000 |