PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
FDA 510(k) clearance K874045 · decided 1987-12-03
Clearance details
- K-number
- K874045
- Device name
- PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
- Applicant
- American Pharmaseal Div. Ahsc
- Decision
- Substantially Equivalent
- Date received
- 1987-10-05
- Decision date
- 1987-12-03
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- NWU
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Valencia, CA, 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 |
|---|---|---|
| CANDELA GUIDEWIRE (K933268) | Candela Laser Corp. | 1994-02-10 |
| BRISTOL BALLON INTRODUCER, MANDRIL SET (K813332) | Inmed Corp. | 1981-12-14 |
Recalls involving this device
No recalls on record reference this clearance.