The following data is part of a premarket notification filed by A Plus International, Inc. with the FDA for Surgiplus Sms Surgical Drape (sterile/non-sterile), Surgiplus Spp With Pe Laminated Surgical Drape (sterile/non-sterile).
| Device ID | K102861 |
| 510k Number | K102861 |
| Device Name: | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) |
| Classification | Drape, 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-01-13 |