SHARPX NEEDLE DESTRUCTION UNIT
FDA premarket approval P980015/S004 · decided 2001-08-15
Approval details
- PMA number
- P980015
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SHARPX NEEDLE DESTRUCTION UNIT
- Generic name
- Sharps needle destruction device
- Applicant
- Innovative Medical Systems, Inc.
- Date received
- 2001-07-16
- Decision date
- 2001-08-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Mountain Brook, AL
- Statement
- APPROVAL FOR LABELING.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VIOLA II DENTAL CAMERA SYSTEM (K973035) | Innovative Medical Systems, Inc. | 1997-09-24 |
| BAZOOKA SYSTEM (K951469) | Innovative Medical Systems, Inc. | 1995-06-28 |
| POSITIVE AIRWAY PRESSURE SYSTEM (K933184) | Innovative Medical Systems, Inc. | 1994-11-28 |
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| LABOTECH AUTOMATED MICROTITER ANALYZER (K922081) | Innovative Medical Systems, Inc. | 1992-09-02 |
| AUTOLOADER (K921005) | Innovative Medical Systems, Inc. | 1992-04-29 |
| PHACO 20/20 SYSTEM I (K915457) | Innovative Medical Systems, Inc. | 1992-02-24 |
| PHACO 3000 LINEAR (K915456) | Innovative Medical Systems, Inc. | 1992-02-12 |