The following data is part of a premarket notification filed by Sscor with the FDA for S-scort(r)duet Model 2014 Portable Suction Pump.
Device ID | K945929 |
510k Number | K945929 |
Device Name: | S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | SSCOR 11064 RANDALL ST. Sun Valley, CA 91352 |
Contact | Sam Say |
Correspondent | Sam Say SSCOR 11064 RANDALL ST. Sun Valley, CA 91352 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-05 |
Decision Date | 1994-12-22 |