510(k) K922086
- Device
- BARD BIOPSY FORCEPS
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K922086
- Product code
- GCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-10-30
- Date received
- 1992-05-04
- Regulation
- 876.1500
- Classification name
- Esophagoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD E FRANKO
- Address
- One Park W. Tewksbury MA US 01876 01876
FDA Registration Numbers#
- 3003782610
- 9610877
- 1017294
- 1320894
Source Documents#
Other 510(k) Records For Product Code GCL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951197 | FE-24X, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 |
| K951198 | FE-34TH, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 |
| K934510 | 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD | Phx Technologies Corp. | 1994-02-17 |
Legacy Summary#
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FDA Review#
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