The following data is part of a premarket notification filed by Sscor with the FDA for S-scort (2500).
Device ID | K964997 |
510k Number | K964997 |
Device Name: | S-SCORT (2500) |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | SSCOR 11064 RANDALL ST. Sun Valley, CA 91352 |
Contact | L S Ay |
Correspondent | L S Ay 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 | 1996-12-16 |
Decision Date | 1997-03-05 |
Summary: | summary |