The following data is part of a premarket notification filed by A Plus International, Inc. with the FDA for Surgiplus Standard Surgical Gown (sterile) ( Non Sterile), Reinforced Surgical Gown (sterile) (non Sterile).
| Device ID | K093169 |
| 510k Number | K093169 |
| Device Name: | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) |
| Classification | Gown, Surgical |
| Applicant | A PLUS INTERNATIONAL, INC. 5138 EUCALYPTUS AVE. Chino, CA 91710 |
| Contact | Solomon Chen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-07 |
| Decision Date | 2009-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00326053117596 | K093169 | 000 |
| 10326053117586 | K093169 | 000 |
| 10326053117579 | K093169 | 000 |
| 10326053117562 | K093169 | 000 |
| 10326053117555 | K093169 | 000 |