Kalrn Face-Life Scissors
FDA 510(k) K772394 · Edward Weck, Inc.
510(k) numberK772394
Submission
- Device name
- Kalrn Face-Life Scissors
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- March 9, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZI – Apparatus, Air Handling, Enclosure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911132 | Multiple, Surgical Drape PackFZI · Traditional | Central Georgia Ancillary Health Systems | 05/06/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | E.M. Adams | 03/21/1991SE |
| K854159 | Ellipti-PunchFZI · Traditional | Alcon Laboratories | 11/15/1985SE |
| K772395 | Davis RhytidectomyFZI · Traditional | Edward Weck, Inc. | 03/09/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
| K914690 | LM15(TM), Catalog Number - 523821GCJ · Traditional | 03/23/1992SE |
| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Kalrn Face-Life Scissors cleared by the FDA?
Kalrn Face-Life Scissors (K772394) received a 510(k) decision of Substantially Equivalent on March 9, 1978, 72 days after the submission was received.
What is the product code of K772394?
The FDA product code is FZI – Apparatus, Air Handling, Enclosure, a Class II (moderate risk) device regulated under 21 CFR 878.5070.