SARNS MEDICAL CART
FDA 510(k) clearance K892052 · decided 1989-06-15
Clearance details
- K-number
- K892052
- Device name
- SARNS MEDICAL CART
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1989-03-29
- Decision date
- 1989-06-15
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LDQ
- Advisory committee
- General Hospital
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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| PIV SYSTEM (K981032) | Medical Solutions, Inc. | 1998-09-02 |
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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |