510(k) K094026
- Device
- STERI-DENT, STERI-SURE
- Applicant
- CPAC, INC.
- 510(k) number
- K094026
- Product code
- KMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-12
- Date received
- 2009-12-30
- Regulation
- 880.6870
- Classification name
- Sterilizer, Dry Heat
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY CRANE
- Address
- 2364 Leicester Rd. P.O. Box 175 Leicester NY US 14481 14481
FDA Registration Numbers#
- 2431273
- 2416455
Source Documents#
Other 510(k) Records For Product Code KMH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Coltene/Whaledent, Inc. | 2005-08-04 |
| K910925 | DISINFECTION WITH THE COX DRY HEAT STERILIZER | Cox Sterile Products, Inc. | 1992-05-08 |
| K910202 | DENTRONIX MODEL 2000 | Dentronix, Inc. | 1991-03-13 |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Dentronix, Inc. | 1988-07-13 |
| K881371 | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE | Cox Sterile Products, Inc. | 1988-04-13 |
| K872643 | COX RAPID HEAT TRANSFER STERILIZER | Cox Sterile Products, Inc. | 1987-10-29 |
| K871615 | U. V. GERMICIDAL UNIT | Lorvic Corp. | 1987-09-11 |
| K851307 | INOX DRY HEAT STERILIZER | Broadwest Corp. | 1985-05-09 |
| K771070 | DRY HEAT STERILIZER | Cpac, Inc. | 1977-07-14 |
Legacy Summary#
summary
FDA Review#
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