The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Oval Shapes.
| Device ID | K973385 |
| 510k Number | K973385 |
| Device Name: | OVAL SHAPES |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Contact | Norbert D Thompson |
| Correspondent | Norbert D Thompson TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B051427060 | K973385 | 000 |
| B051427050 | K973385 | 000 |
| B051427040 | K973385 | 000 |
| B051427030 | K973385 | 000 |