The following data is part of a premarket notification filed by Asc Corp. with the FDA for Sulky Special.
Device ID | K863450 |
510k Number | K863450 |
Device Name: | SULKY SPECIAL |
Classification | Stroller, Adaptive |
Applicant | ASC CORP. 6518 DENTON DR. Troy, MI 48098 |
Contact | Olav H Brannstrom |
Correspondent | Olav H Brannstrom ASC CORP. 6518 DENTON DR. Troy, MI 48098 |
Product Code | LBE |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-03 |
Decision Date | 1986-10-23 |