STERILE BASIN SETS
FDA 510(k) clearance K813012 · decided 1981-11-06
Clearance details
- K-number
- K813012
- Device name
- STERILE BASIN SETS
- Applicant
- Medspec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-27
- Decision date
- 1981-11-06
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- LDQ
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EC-7701 FLUID WARMING CABINET (K993797) | Enthermics Medical Systems, Inc. | 2000-01-20 |
| HOT SHOT FLUID WARMER IV FLUIDS (K992258) | Infra-Med Technologies, Inc. | 2000-01-12 |
| PIV SYSTEM (K981032) | Medical Solutions, Inc. | 1998-09-02 |
| CONTROLLED TEMPERATURE CABINET SYSTEM (K973747) | Smith | 1998-05-07 |
| ACU-HALT (K955661) | Glederer & Co., Inc. | 1996-12-30 |
| ACU-LAB (K955776) | Glederer & Co., Inc. | 1996-06-05 |
| ACU-HALT (K945374) | Eva-Health USA, Inc. | 1995-08-09 |
| PERSONAL ALARM SYSTEM (PAS) (K944961) | Cytoprobe Corp. | 1995-08-07 |
| PALCO LABS COLD POUCH (K942810) | Palco Laboratories, Inc. | 1995-06-28 |
| MEDICAL PROCEDURE TRAY, MODIFICATION (K930884) | Enpak Medical Corp. | 1995-03-21 |
| MEDICOOL PROTECTALL (K934703) | Avc Regulatory Compliance/Technical Services | 1994-01-26 |
| NORTEC STERILE WATER FOR DEVICE IRRIGATION (K925593) | North American Sterilization & Packaging Co. | 1993-12-03 |
Recalls involving this device
No recalls on record reference this clearance.