The following data is part of a premarket notification filed by Molloy Corp. with the FDA for Molloy Intubating Stylette.
| Device ID | K943104 |
| 510k Number | K943104 |
| Device Name: | MOLLOY INTUBATING STYLETTE |
| Classification | Stylet, Tracheal Tube |
| Applicant | MOLLOY CORP. FOURTH AND WALNUT STREETS Lebanon, PA 17042 |
| Contact | William T Merchant |
| Correspondent | William T Merchant MOLLOY CORP. FOURTH AND WALNUT STREETS Lebanon, PA 17042 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1996-04-18 |