The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Spiral-flex.
Device ID | K860105 |
510k Number | K860105 |
Device Name: | SPIRAL-FLEX |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | Steen, Ph.d. |
Correspondent | Steen, Ph.d. SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-13 |
Decision Date | 1986-03-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
44026704617164 | K860105 | 000 |
34026704759942 | K860105 | 000 |
34026704759959 | K860105 | 000 |
24026704759969 | K860105 | 000 |
24026704759976 | K860105 | 000 |
24026704397451 | K860105 | 000 |
24026704397468 | K860105 | 000 |
24026704397475 | K860105 | 000 |
44026704397486 | K860105 | 000 |
24026704397499 | K860105 | 000 |
44026704617126 | K860105 | 000 |
44026704617133 | K860105 | 000 |
44026704617140 | K860105 | 000 |
34026704617150 | K860105 | 000 |
24026704759938 | K860105 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPIRAL-FLEX 73768215 1559680 Live/Registered |
SHERIDAN CATHETER CORP. 1988-12-02 |