BAZOOKA SYSTEM
FDA 510(k) clearance K951469 · decided 1995-06-28
Clearance details
- K-number
- K951469
- Device name
- BAZOOKA SYSTEM
- Applicant
- Innovative Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-30
- Decision date
- 1995-06-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FNM
- Device class
- 2
- Regulation number
- 880.5550
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S005) | Innovative Medical Systems, Inc. | 2002-06-12 |
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S004) | Innovative Medical Systems, Inc. | 2001-08-15 |
| SHARP(X)TM NEEDLE DESTRUCTION UNIT (P980015/S003) | Innovative Medical Systems, Inc. | 1999-09-17 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S002) | Innovative Medical Systems, Inc. | 1999-03-19 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S001) | Innovative Medical Systems, Inc. | 1998-12-14 |
| SHARPX (P980015) | Innovative Medical Systems, Inc. | 1998-08-06 |