BASIN, RECTANGULAR WASH
FDA 510(k) clearance K760495 · decided 1976-11-12
Clearance details
- K-number
- K760495
- Device name
- BASIN, RECTANGULAR WASH
- Applicant
- Landmark Plastics
- Decision
- Substantially Equivalent
- Date received
- 1976-08-23
- Decision date
- 1976-11-12
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FNY
- Device class
- 1
- Regulation number
- 880.6730
- Medical specialty
- General Hospital
- 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 |
|---|---|---|
| AAP DOSIMETRY RELEASE OR BASIN SETS (K832826) | American Hospital Supply Corp. | 1984-04-23 |
| BASIN PACK (K802538) | Texas Medical Products, Inc. | 1980-10-31 |
| STERILE SPONGE BOWLS (K800440) | Premium Plastics, Inc. | 1980-04-29 |
| STERILIZATION PROCESS/PLACENTA BASIN (K792625) | Procter & Gamble Mfg. Co. | 1980-01-16 |
| 8 EMESIS BASIN (K771733) | Bemis Health Care | 1977-09-28 |
| BASIN, ROUND WASH (K760494) | Landmark Plastics | 1976-11-12 |
| BASIN, LARGE OR SMALL (K760492) | Landmark Plastics | 1976-11-12 |
| BASIN, STERILE (#3200) (K760085) | Concord Laboratories, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.