Self-Contained Surgical Slush Freezer
FDA 510(k) K913777 · Taylor Corp.
510(k) numberK913777
Submission
- Device name
- Self-Contained Surgical Slush Freezer
- Applicant
- Taylor Corp.
Rockton, IL, US - Received
- August 14, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JRM – Freezer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921570 | ORS-300JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921569 | ORS-200JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921568 | ORS-100JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K915427 | ORS-1000JRM · Traditional | Mnlase, Inc. | 01/07/1992SE |
| K894006 | Saniserv Surgical Slush SystemJRM · Traditional | Saniserv, Inc. | 11/03/1989SE |
| K782077 | Lancer Ice CubeJRM · Traditional | Sherwood Medical Industries | 04/03/1979SE |
Questions and answers
When was Self-Contained Surgical Slush Freezer cleared by the FDA?
Self-Contained Surgical Slush Freezer (K913777) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 42 days after the submission was received.
What is the product code of K913777?
The FDA product code is JRM – Freezer, a Class I (low risk) device regulated under 21 CFR 862.2050.