The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Lighted Flexguide (modification).
| Device ID | K953677 |
| 510k Number | K953677 |
| Device Name: | LIGHTED FLEXGUIDE (MODIFICATION) |
| Classification | Stylet, Tracheal Tube |
| Applicant | SCIENTIFIC SALES INTL., INC. 2001 CHEVY CHASE BLVD. Kalamazoo, MI 49008 |
| Contact | Nicholas Schmelzer |
| Correspondent | Nicholas Schmelzer SCIENTIFIC SALES INTL., INC. 2001 CHEVY CHASE BLVD. Kalamazoo, MI 49008 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-08-25 |