The following data is part of a premarket notification filed by Sklar Corp. with the FDA for Sklar Surgical Gown.
| Device ID | K082479 |
| 510k Number | K082479 |
| Device Name: | SKLAR SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | SKLAR CORP. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Natalya Valerio |
| Correspondent | Natalya Valerio SKLAR CORP. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50649111055094 | K082479 | 000 |
| 50649111054981 | K082479 | 000 |
| 50649111054677 | K082479 | 000 |
| 50649111054561 | K082479 | 000 |