The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Surgical Drape.
| Device ID | K873313 |
| 510k Number | K873313 |
| Device Name: | SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234 |
| Contact | Zamba, P.e. |
| Correspondent | Zamba, P.e. AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-17 |
| Decision Date | 1987-09-04 |