The following data is part of a premarket notification filed by Fortress Scientific Ltd. with the FDA for S500 Seating System.
Device ID | K933863 |
510k Number | K933863 |
Device Name: | S500 SEATING SYSTEM |
Classification | Wheelchair, Powered |
Applicant | FORTRESS SCIENTIFIC LTD. C/O FOLEY & LARDNER 3000 K STREET, N.W. Washington, DC 20007 |
Contact | Ilene Knable Gotts |
Correspondent | Ilene Knable Gotts FORTRESS SCIENTIFIC LTD. C/O FOLEY & LARDNER 3000 K STREET, N.W. Washington, DC 20007 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-06 |
Decision Date | 1994-03-28 |