The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Applied Access Seal.
| Device ID | K012968 |
| 510k Number | K012968 |
| Device Name: | APPLIED ACCESS SEAL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-12-03 |
| Summary: | summary |