The following data is part of a premarket notification filed by H&h Medical Corporation with the FDA for H&h Emergency Cricothyrotomy Kit.
| Device ID | K133528 |
| 510k Number | K133528 |
| Device Name: | H&H EMERGENCY CRICOTHYROTOMY KIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | H&H MEDICAL CORPORATION 290 TURNPIKE RD. SUITE 200 Westborough, MA 01581 |
| Contact | J. Lawrence Stevens |
| Correspondent | J. Lawrence Stevens H&H MEDICAL CORPORATION 290 TURNPIKE RD. SUITE 200 Westborough, MA 01581 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-07-03 |
| Summary: | summary |