SPLASH ASSIST
FDA 510(k) clearance K952303 · decided 1995-08-24
Clearance details
- K-number
- K952303
- Device name
- SPLASH ASSIST
- Applicant
- Innovative Outsourcing Solutions
- Decision
- Substantially Equivalent
- Date received
- 1995-05-16
- Decision date
- 1995-08-24
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- LYU
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- N. Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| FAR-EAST BOUFFANT CAPS (K970988) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| DISPOSABLE APRON (K964364) | Instrument Makar, Inc. | 1997-02-25 |
| DEPUY DISPOSABLE FILTER/HOOD (K961791) | Depuy, Inc. | 1996-08-09 |
| AMMI MAGNI-GUARD (K961454) | American Medical Mfg., Inc. | 1996-07-25 |
| SLOAN STA-DRI PANT PROTECTOR (K945302) | Sloan Corp. | 1996-03-19 |
| ULTRAFIT LINERS (K954314) | Stahmer Weston Scientific | 1995-12-28 |
| I-SPOUSE (K953089) | Products For Medicine | 1995-10-16 |
| ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (K942200) | Thantex Specialties, Inc. | 1995-08-07 |
| SLOAN STA-DRI BOOTLEG LEGGING (K944276) | Sloan Corp. | 1995-07-31 |
| SLOAN STA-DRI SURGICAL JUMPSUIT (K944118) | Sloan Corp. | 1995-07-31 |
Recalls involving this device
No recalls on record reference this clearance.