The following data is part of a premarket notification filed by Gilbert Surgical Instruments, Inc. with the FDA for Abelson Cricothyrotomy Cannula.
| Device ID | K952401 |
| 510k Number | K952401 |
| Device Name: | ABELSON CRICOTHYROTOMY CANNULA |
| Classification | Needle, Emergency Airway |
| Applicant | GILBERT SURGICAL INSTRUMENTS, INC. 115 HARDING AVE. Bellmawr, NJ 08030 |
| Contact | Gilbert Goldberg |
| Correspondent | Gilbert Goldberg GILBERT SURGICAL INSTRUMENTS, INC. 115 HARDING AVE. Bellmawr, NJ 08030 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-07-11 |