510(k) K854159
- Device
- ELLIPTI-PUNCH
- Applicant
- ALCON LABORATORIES
- 510(k) number
- K854159
- Product code
- FZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-15
- Date received
- 1985-10-11
- Regulation
- 878.5070
- Classification name
- Apparatus, Air Handling, Enclosure
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- REBECCA G WALKER
- Address
- 6201 S. Fwy. R7-14 Fort Worth TX US 76134 76134
FDA Registration Numbers#
- 3016750643
- 3044563550
- 1526611
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911132 | MULTIPLE, SURGICAL DRAPE PACK | Central Georgia Ancillary Health Systems | 1991-05-06 |
| K910468 | STERILE DISPOSABLE DRAPE(S) | E.M. Adams | 1991-03-21 |
| K772394 | KALRN FACE-LIFE SCISSORS | Edward Weck, Inc. | 1978-03-09 |
| K772395 | DAVIS RHYTIDECTOMY | Edward Weck, Inc. | 1978-03-09 |
Legacy Summary#
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FDA Review#
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